209th Meeting (R-II North)

MINUTES OF 209 TH MEETING OF THE DRUGS REGISTRATION BOARD HELD ON

31 st AUGUST-1 ST SEPTEMBER, 2007 (Regn II- North)

The Director General Health, Maj. Gen. (R) Shahida Malik HI (M), chaired the 209th meeting of the

Drugs Registration Board held on 31st – 1st September, 2007 in the Committee Room of Ministry of Health,

Block-C, Pakistan Secretariat, Islamabad. The Chairperson welcomed all the members of the Board. The

following members attended the meeting: -

1. Maj. Gen. (R) M.I. Burney HI (M) SI,National Institute of HealthIslamabad.

2. Maj. Gen. (R) Nasir-ul-Islam HI (M)Rawalpindi.

3. Col. Aslam Khan, Classified Medical Specialist Military Hospital, Quetta.

4. Mr. Abdul Latif Sheikh,Director Pharmacy, Nutrition and CSSD Services Aga Khan University HospitalKarachi

5. Dr. I.U. Baig, Surgeon, Federal Government Services Hospital,Islamabad

6. Prof. Dr. Ijaz Ahmad, University of Veterinary and Animal Sciences,Lahore

7. Dr. R.H. Usmani,Animal Husbandry Commissioner, Ministry of Food, Agriculture and Livestock,Islamabad.

8. Dr. Sulman HameedAssistant Animal Husbandry Commissioner,

Ministry of Food, Agriculture and Livestock,Islamabad.

9. Arshad M. Tabassum, Deputy Secretary,Law, Justice and Human Rights, Division Islamabad

10. Representative of Director General Health Services, Government of Punjab,Lahore.

11. Representative of Director General Health Services, Government of NWFP,Peshawar

12. Mr. Atta-u-Rehman, Chief Drug Inspector Representative of Director General Health Services, Government of Balochistan,Quetta.

13 Mrs. Yasmeen Abbassi, Controller of Patents Karachi.

14. Deputy Secretary,M/o Industries & Production Islamabad

15. Mr. Amanulha,Cost Accountant, Ministry of Health,Islamabad.

16. Dr. Farnaz Malik, SecretaryDrug Controller, Ministry of Health,Islamabad.

17. Mr. Zahid Saeed, ObserverPakistan Pharmaceuticals Manufacturers Association,Karachi

18. Mr. M. Zafar Mooraj, ObserverAdvisor, Pharma Bureau,Karachi

19. Mr. Salahuddin Sheikh ObserverRepresentative of Pakistan Chemists and Druggists Association,Karachi.

20. Dr. Talib Lashari Observer The Executive Coordinator, The Network for Consumer Protection, Islamabad.

Confirmation of the Minutes of the 207th meeting.

The Drugs registration Baord confirmed the minutes of the 207th meeting held on 20-21 July

2007.

Note: - Approved* products are approved subject to the submission of stability testing and validation of method of testing and as per policy of ten products per section.

Registration of drugs.

S. No.

Name of the firm

Brand name/ Label claim Pack size Proposed Price

Remarks.

1. M/s. Himont Pharma,Lahore.

Montelair Chewable Tablets.Each Tablet Contains:-Montelukast as Sodium…5mg.

14’s Rs. 284.00 Approved*

2. -do- Montelair Sachet.Each Sachet Contains:-Montelukast as Sodium….5mg.

14’s Rs. 275.00 -do-

3. -do- Hiplex Tablets.Each Tablet Contains:-Iron as Polymaltose Complex……………..100mg.Folic Acid……………0.35mg.

2x10’s Rs. 195.65 -do-

4. -do- Clotles SS Injection.Each ml Contains:-Enoxaparin Sodium……20mg.(USP)

1’s Not mention. Rejected as the firm has

no section for the

manufacturing of the product.

5. -do- Redrose Tablets.Each Tablet Contains:-Iron as Polymaltose Complex …………….100mg

2x10’s Rs. 195.00 Approved*.

6. -do- Hixamic Capsules.Each Capsule Contains:-Tranexamic Acid………500mg.

2x10’s Rs. 190.00 -do-

7. -do- Hixamic Injection IM/IV.Each Ampoule Contains:-Tranexamic Acid………500mg.

10’s Rs. 438.00 -do-

8. M/s. Martin Dow Pharma,

Lahore.

Tilox Tablets.Each Tablet Contains:-Gatifloxacin……………400mg.

5’s10’s

Rs. 180.00Rs. 340.00

Rejected due to potential

hazards.

9. -do- Tilox Tablets.Each Tablet Contains:-Gatifloxacin……………200mg.

10’s30’s

Rs. 200.00Rs. 540.00

-do-

10. -do- Telmis Tablets.Each Tablet contains:-Terlmisartan…………..80mg.

10’s30’s

Rs. 640.00Rs. 1860.00

Approved*.

11. -do- Telmis Tablets.Each Tablet contains:-

10’s30’s

Rs. 360.00Rs. 1020.00

-do-

Terlmisartan…………..40mg.12. -do- Telmis Tablets.

Each Tablet contains:-Terlmisartan…………..20mg.

10’s30’s

Rs200.00Rs. 540.00

-do-

13. -do- Aqualac Syrup.Each 5ml Contains:-Lactulose……………..3.35gm

60ml120ml240ml

Rs. 74.00Rs. 145.00Rs. 270.00

-do-

14. -do- Arsofin Tablets.Each Tablet Contains:-Diclofenac Sodium………75mgMisoprostol…………….200mcg

20’s30’s

Rs. 400.00Rs. 540.00

-do-/comparison of the dissolution

profile with originator.

15. -do- Zoprasid Tablets.Each Tablet Contains:-Aripiprazole…………..30mg.

10’s20’s30’s100’s

Rs. 850.00Rs. 1680.00Rs. 2490.00Rs. 8200.00

Approved*

16. -do- Zoprasid Tablets.Each Tablet Contains:-Aripiprazole…………..10mg.

10’s20’s30’s100’s

Rs. 450.00Rs. 880.00Rs. 1290.00Rs. 4204.00

-do-

17. -do- Xanbit Gel.Each gram Contains:-Naproxen Sodium……10% w/w

25gm50gm

Rs. 160.00Rs. 300.00

-do-

18. M/s. Shaigan Pharma,

Islamabad.

Cefdin Dry Suspension.Each 5ml Contains:-Cefdinir……………..125mg.

Not mention

Not mention. Approved*/Installation

and verification of HVAC system in the section.

19. -do- Cefdin Dry Suspension.Each 5ml Contains:-Cefdinir……………..250mg.

-do- -do- -do-

20. -do- Oscar Suspension.Each 5ml Contains:-Ossein Hydroxihepatite Compound 250mg eq. to Calcium…………..53.5mg.Phosphorous………24.8mg.Residual Mineral Salt…7.5mgProteins……………..87.5mg.Trace elements FI, Mg, Fe, Zn, Cu, Ni

-do- -do- Rejected as the firm has no testing facility for

trace elements.

21. -do- Prezal Capsules.Each Capsule Contains:-Lansoprazole………….30mg.

-do- -do- Approved*/ Installation

and verification of HVAC system

in section.

22. -do- Prezal Capsules. -do- -do- -do-

Each Capsule Contains:-Lansoprazole………….15mg.

23. -do- Cefdin Capsules.Each Capsule Contains:-Cefdinir………………..600mg

-do- -do- -do-

24. -do- Anomol Eye Drops.Each ml Contains :-Latanoprost…………..50mcg.Timolol as Maleate……5mg.

-do- -do- Approved*/ Change of

name.

25. -do- Cefdin Capsules.Each Capsule Contains:-Cefdinir………………..300mg



in Section.26. -do- Sporazole Capsules Delayed

Release.Each Capsule Contains:-Itraconazole…………..100mg.

-do- -do- -do-/ comparison of

dissolution profile with

the originator.27. -do- Oscar Tablets

Each Tablet Contains:-Ossein Mineral Complex830mg eq. to Calcium…………..177.6mg.Phosphorous………82.2mg.Residual Mineral Salt…24.9mgCollagen………………224mgOther Proteins………..66.4mg.Trace elements FI, Mg, Fe, Zn, Cu, Ni.

Rejected as the firm has no testing

facility for the trace elements.

28. -do- Jovit Tablets.Each Tablet Contains:-Glucosamine Sulphate…..750mgChondroitin Sulphate…..600mg.(USP)

-do- -do- Rejected as the firm did not apply on

form 5-D/ size of the tablet is

not suitable for oral

administration.

29. -do- Jovit Plus Tablets.Each Tablet Contains:-Glucosamine Sulphate…..750mgChondroitin Sulphate…..600mg.Vitamin D…………….5mcg.Vitamin C…………..100mg.Calcium Carbonate.....100mg.

-do- -do- Rejected as the firm did not apply on

form 5-D/ size of the tablet is

not suitable for oral

administration+ being an irrational

combination.

30. -do- Mincy Tablets.Each Tablet Contains:-Minocycline as HCl…….100mg


and verification of HVAC system in the section.

31. -do- Mincy Tablets.Each Tablet Contains:-Minocycline as HCl…….50mg

-do- -do- Rejected as the reference of the me-too

product quoted is

wrong/ The firm did not

apply on form 5-D.

32. -do- Mospa Tablets.Each Tablet Contains:-Mosapride Citrate………5mg.

-do- -do- Rejected as the firm did not apply on form 5-D &

quoted reference of the me-too product is

wrong. 33. -do- Gasrid Tablets.

Each Tablet Contains:-Itopride HCl……………50mg.

-do- -do- Approved*/ installation


in section.34. M/s. Ferozsons

Laboratoires,Nowshera.

Centaurus Tablets.Each Tablet contains:-Entecavir as Monohydrate 0.5mg

3x10’s Rs. 325.00/ Tablet.

Deferred till the

confirmation of Patent

status of BMS for Baraclude.

35. -do- Centaurus Tablets.Each Tablet contains:-Entecavir as Monohydrate…1mg

3x10’s Rs. 617.00/ Tablet.

-do-

36. -do- Orion Tablets.Each Tablet contains:-Olmesartan Medoxomil….20mg

10’s Rs. 340.00 Approved*. Although it is a new drug but

the Registration

Board decided that no need of

expert opinion.

37. -do- Orion Tablets.Each Tablet contains:-Olmesartan Medoxomil….10mg

10’s Rs. 180.00 -do-

38. -do- Orion Tablets. 10’s Rs. 610.00 -do-

Each Tablet contains:-Olmesartan Medoxomil….40mg

39. -do- Orion DIU Tablets.Each Tablet Contains:-Olmesartan Medoxomil…40mgHydrochlorothiazide USP..25mg

10’s Rs. 617.00 -do-

40. -do- Orion DIU Tablets.Each Tablet Contains:-Olmesartan Medoxomil…20mgHydrochlorothiazide USP…………………..12.5mg

10’s Rs. 340.00 -do-

41. -do- Orion DIU Tablets.Each Tablet Contains:-Olmesartan Medoxomil…40mgHydrochlorothiazide USP…………………..12.5mg

10’s Rs. 614.00 -do-

42. -do- Orion DIU Tablets.Each Tablet Contains:-Olmesartan Medoxomil…20mgHydrochlorothiazide USP…………………..25mg

10’s Rs. 347.00 -do-

43. -do- Omgea Rapid Capsules.Each Capsule contains:-Omeprazole USP………20mgSodium Bicarbonate USP…….1100mg

10’s Rs. 19.9/ Capsule.

Deferred as the drug is already in

expert opinion/chang

e of name.44. -do- Omgea Rapid Capsules.

Each Capsule contains:-Omeprazole USP………40mgSodium Bicarbonate USP…….1100mg


-do-

45. -do- Aurora Plus Tablets.Each Tablet contains:-Rosuvastatin as Calcium…10mgEzitimibe……………..10mg

10’s Rs. 22.00/ Tablet.

Rejected as the said

combination is not approved by FDA and

not included in BNF.


10’s Rs. 38.00/ Tablet.

-do-


10’s Rs. 65.00/ Tablet.

-do-

48. -do- Esomeg Capsules.Each Capsule Contains:-Esomeprazole as Magnesium Trihydrate Pellets………20mg

2x7’s Rs. 330.00 Approved*

49. M/s. Z-Jans Pharmaceutica

lsPeshawar.

Oximed Capsules.Each Capsule Contains:-Cefpodoxime as proxetil…………….100mg

10’s Rs. 410.00 Rejected as the firm did not apply on Form 5-D. The drug is

me-too in the tablet dosage

form/ 50. -do- Efexze XRCapsules.

Each Capsule Contains:-Venlafaxine…………….75mg

50’s Rs. 570.00 Approved*/ comparison of the dissolution

profile with the originator/

Installation and

verification of HVAC system

in the firm.51. -do- Oximed DS Suspension.

Each 5ml Contains :-Cefpodoxime as Proxetil…40mg

50ml100ml

Rs. 290.00Rs. 450.00

Approved*/ Installation


of the firm.52. -do- Ecita Tablets.

Each Tablet Contains:-Escitalopram………….10mg.

14’s Rs. 688.00 -do-

53. -do- Z-Kast chewable Tablets.Each Tablet Contains:-Montelukast as Sodium….5mg.

30’s Rs. 300.00 -do-

54. -do- Z-Kast Tablets.Each Tablet Contains:-Montelukast as Sodium….10mg.

30’s Rs. 570.00 -do-

55. M/s. Standpharm,

Lahore.

Angiocam Tablets.Each Tablet contains:-Candesartan Cilexetil……16mg.

14’s Rs. 16.50/ Tablet.

Approved subject to the renewal of the

firm.56. -do- Ostact Tablets.

Each Tablet contains:-Risedronate Sodium……..5mg.

2x14’s Rs. 60.00/ Tablet.

-do-

57. -do- Ostact Tablets.Each Tablet contains:-Risedronate Sodium……..35mg.

4’s Rs. 463.00/ Tablet.

-do-

58. -do- Genol Tablets.Each Tablet Contains:-Ginkobiloba Extract…….40mg.

20’s Rs. 15.00/ Tablet.

-do-

59. -do- Virolem Tablets.Each Tablet contains;-Lamivudine……………..100mg

14’s Rs. 98.21/ Tablet.

-do-

60. -do- Angiocam Tablets.Each Tablet contains:-Candesartan Cilexetil……8mg.

14’s Rs. 8.6/ Tablet. -do-

61. -do- Angiocam Tablets.Each Tablet contains:-Candesartan Cilexetil……4mg.

14’s Rs. 5.5/ Tablet. -do-

62. -do- Maltron Chewable Tablets.Each Tablet Contains:-Iron as Polymaltose Complex ………………..100mgFolic Acid………….0.35mg.

10’s Rs. 9.5/ Tablet. -do-.

63. -do- Ferifen Chewable TabletsEach Tablet contains:-Iron Polymaltose Complex……………….100mg

2x10’s Rs. 7.5/ Tablet. -do-

64. -do- Maltron Syrup.Each 5ml Contains:-Iron as Polymaltose Complex ………………..50mgFolic Acid………….0.35mg.

60ml Rs. 75.00 -do-

65. -do- Ferifen Drops.Each ml contains:-Iron Polymaltose Complex……………….50mg

30ml Rs. 110.00 -do-

66. -do- Ferifen Syrup.Each 5ml contains:-Iron Polymaltose Complex……………….50mg

60ml Rs. 90.00 -do-

67. M/s. Faisal Pharmaceutica

lsFaisalabad.

Septa Chlor Tulle Dressing.Chlorhexidine Acetate BP Dressing.

10x10cm15x20cm15x1.5m15x2m

Rs. 18.00 Deferred subject to the expert opinion

by Dr. I.U. Baig.

68. M/s. Cotton Craft (Pvt)

Ltd ;Lahore.

Triangular Bandage.Triangular Calico Bandage.BPC

36x36x51, Inches

Rs. 20.00 Approved*

69. -do- Absorbent Ribbon Gauze.Absorbent Ribbon Gauze BPC

1.25cm x 5m

2.54cm x 5m

Rs. 10.00Rs. 18.00

Approved*

70. -do- Dressing ShellP.Med. Specifications

Not mentioned.

Rs. 40.00 Approved*

71. M/s. Surge Laboratories,Sheikhupura.

Bucain Injection.Each ml Contains:-Bupivacaine HCl BP….7.5mg

5’s x 2ml Rs. 220. 00 Approved as the renewal of

the firm is pending.

72. -do- Bucain Injection.Each ml Contains:-Bupivacaine HCl BP….0.5mg

5’s10’s

Rs. 110.00Rs. 220.00

-do-

73. -do- Celine Infusion.Each 100ml Vial Contains:-Sodium Chloride BP…..0.9gm

1’s Rs. 45.00 -do-

74. M/s. Schazoo Laboratories,

Lahore.

Klarox Suspension.Each 5ml Contains:-Clarithromycin USP…..125mg. (USP)

60ml Not mentioned. Approved*.

75. -do- Klarox Tablets.Each Tablet Contains:-Clarithromycin USP…..250mg.(USP)

10’s Rs. 358.00 -do-

76. -do- Klarox Tablets.Each Tablet Contains:-Clarithromycin USP…..500mg.(USP)

10’s Rs. 648.00 -do-

77. -do- Levo Tablets.Each Tablet contains:-Levofloxacin…………..250mg.

10’s Rs. 380.00 Approved*/change of

name.

78. -do- Levo Tablets.Each Tablet contains:-Levofloxacin…………..500mg.

10’s Rs. 710.00 -do-

79. M/s. Amson Vaccine & Pharma,

Islamabad.

Neo-Cotecxin Tablets.Each Tablet Contains:-Artemether………….20mg.Lumefantrin……….120mg.


80. -do- Amsolide Gel.Each Gram Contains:-Nimesulide BP………..10mg.

10mg. Rs. 110.00 Deferred.

81. -do- Funginor Capsules.Each Capsule Contains:-Itraconazole BP……….100mg.


82. -do- Neo-Cotecxin Tablets.Each Tablet Contains:-Artemether………….80mg.Lumefantrin……….480mg.


Rejected as the said

strength is not approved by

WHO.83. -do- Amsotyph Injection.

Each 05ml contains:- Vi Capsular Poly Saccharide Powder (strain Salmonella Typhi Ty 2)………………..0.025mg

1’s Rs. 500.00 Deferred for the biological committee.

84. M/s Global Pharmaceutical, Islamabad.

Zetivast Tablets.Each tablet contains:-Ezetimibe…………….10mg.Simvastatin…………...20mg.

2x10’s As per SRO Approved*

85. -do- Glimetin Tablets.Each tablet contains:-Glimipride…………..2mg.Metformin HCl……..500mg.

2x10’s -do- -do-

86. -do- Glovan Tablets.Each tablet contains:-Valsartan …………..160mg.

14’s -do- -do-

87. -do- Glo-Spa Injection.Each ampoule contains:-Difemerine………….1mg.

6’s -do- -do-

88. -do- Glopril Tablets.Each tablet contains:-Ramipril……………5mg.

2x10’s -do- -do-

89. -do- Glopril Tablets.Each tablet contains:-Ramipril……………2.5mg.

2x10’s -do- -do-

90. -do- Glocand Tablets.Each tablet contains:-Candesartan……………16mg.

4x7’s -do- -do-

91. -do- Simlovast Tablets.Each tablet contains:-Simvastatin……………..20mg.Simcolol………………..20mg.

14’s -do- Rejected as the firm did not apply on form 5-D. &

due to the wrong

reference of the me-too product.

92. -do- Di-Glovan Tablets. 14’s -do- Approved*

Each tablet contains:-Valsartan……………..160mg.Hydrochlortiazide…….25mg.

93. M/s Unexo Labs, Lahore.

Idogil Tablets.Each tablet contains:-Di-Iodohydroxyquinolone BP………………….325mg.Metronidazole………250mg.

10x6’s -do- Approved*. Installation

and verification of

the HVAC system of the

section.94. M/s. Shaigan

Pharmaceuticals.

Rawalpindi.

Esso-40 Injection.Each vial Contains:-Esomeprazole Sodium……………..…42.8 mgsEq. to Esomeprazole…….40 mgs

1’s Rs.595.00 Rejected as the firm has no approved area for the lyophilized products.

95. M/s. CCL, Lahore.

Rosimet 4.5 tablets.Each tablet contains:-Rosiglitazone…………..4mg.Metformin…………….500mg.

10’s Rs. 1041.46 Rejected as the renewal of the firm is pending on its part.

96. -do- Rosimet 2. tablets.Each tablet contains:-Rosiglitazone…………..2mg.Metformin…………….1000mg.

10’s Rs. 610.00 -do-

97. -do- Rosimet 1.5 tablets.Each tablet contains:-Rosiglitazone…………..1mg.Metformin…………….500mg.

10’s Rs. 357.36 -do-

98. -do- Rosimet .5 tablets.Each tablet contains:-Rosiglitazone…………..2mg.Metformin…………….500mg.

10’s Rs. 595.12 -do-

99. -do- Rosimet 4.1 tablets.Each tablet contains:-Rosiglitazone…………..4mg.Metformin…………….1000mg.

10’s Rs. 1075.00 -do-

100. -do- Crestat Tablets.Each tablet contains:-Rosuvastatin as Calcium…………………..5mg.

1’s10’s

Rs. 15.00Rs. 150.00

-do-

101. M/s. Medizan Laboratories,

Islamabad

Olanzan-10 Tablets.Each tablet contains:-Olanzapine Citrate……….10mg.


102. -do- Olanzan-5 Tablets.Each tablet contains:-Olanzapine Citrate……….5mg.

10’s Rs. 90.00 -do-

103. -do- Glucosazan Plus Tablets:-Each tablet contains:-Glucosamine Sulphate USP………………500mgChondroiton Sulphate USP………..…….400mg(USP)

10’s Rs. 150.00 -do-

104. -do- Leflozan-20 Tablels.Each tablet contains:-Leflonamide………….20mg.

3x10’s Rs. 28.00/Tablet

-do-

MISCELLANEOUS CASES

Case No. 1.

The DDC (RRR) has forwarded the case of “Lisodim (Diclofenac Sodium) Tablets 25mg” (Reg. No.

023823) of M/s. Surge Laboratories (Pvt.) Ltd; Sheikhupura for renewal of registration. During scrutiny it has been

observed that the above mentioned product was registered in the name of M/s. Surge Laboratories through toll

manufacturing by M/s. Nabiqasim Industries (Pvt.) Ltd; Karachi. Initially the product was registered on 26-10-2001 which

has been expired on 25-10-2006.

Decision: The request of the firm was rejected.

Case No. 2.

DDC (RRR) has forwarded the following application of M/s. Chiesi Pharmaceuticals (Pvt.) Ltd; Lahore:-

S. No. Name of Drug Reg. No.

1. Riacen Capsule 20mgEach capsule contains:-Piroxicam .................. 20mg

009542

The product was initially registered for import on 25-02-1987 and they were granted the transfer of registration

through toll manufactured by M/s. Highnoon Laboratories Lahore on 02-03-2001 for period of 02 years. The toll

manufacturing period has been expired on 01-03-2003.


Case No. 3.

M/s. Hayan Pharma Lahore have informed that they were granted the permission for extension in bulk import and

local repacking by M/s. Pulse Pharmaceuticals (Pvt.) Ltd; Lahore for a period of one year for the following product

S. No. Name of Drugs Reg. No.

1 Gastriferm Capsules

Each gelatin capsule contains:-

Enterococcus faecium M74…..250 Milion bacteria

Magnesium Stearate ………………..205mg

016327

2. Fiberform sachets

Each dose contains:-

Testa Triticum Purif………………36gm

016326

3. Fiberform Mix Sachets

Each Sachet of 5gm

Fiberform Mix Contains:-

Testa Triticum Tricum Purif………306gm

016328

4 Q-10 (Normorol) Capsules

Each Capsule contains:-

Ubibecarenone……………..10mg

017876

5. Q-10 Extra (Normorol) Capsules

Each Capsule contains:-

Ubibecarenone……………..30mg

017877

They are in the process of creating their own manufacturing facility under the name of SwePak Pharma for which

they have already got the site approval from Ministry of Health and now they are waiting for the approval of layout plan

that they have submitted to the aforementioned health authority on January 17, 2007.

They have informed that as soon as they get the approval, they will make every possible effort to start

manufacturing process immediately with in three to four years to start producing these imported medicines locally

enabling them to use their own premises for repacking of the same.

They have therefore, requested to extend the period of local repacking from 01 year to 05 years enabling them to

concentrate fully and more effectively on the manufacturing process of the above mentioned project.

M/s hayan Pharma was given permission to import and local repacking of above products for a period of one year (09-02-

2007 to 08-02-2008)

Decision: The board extended the period from one year to 2& ½ years subject to the submission of the progress report by

the firm.

Case No. 4.

The DDC (RRR) has forwarded the case of M/s. Cirin Pharmaceuticals Hattar wherein he has informed that M/s.

Cirin Hattar have applied for the renewal of the registration of “Tramed (Tramadol HCl) Injections 50mg ” (Reg. No.

024430). During the scrutiny, he observed that the above mentioned product had been registered in the name of M/s. Cirin

Pharmaceuticals Hattar through toll manufactured by M/s. StandPharm Lahore. He has therefore forwarded the case for

further action. The initial date of registration of the drug is 26-03-2002. The permission is expiring on 25-03-2007. They

have deposited fee of Rs.4000/- for this purpose.


Case No. 5.

The DDC (RRR) has forwarded the case of M/s. Cirin Pharmaceuticals Hattar wherein he has informed that M/s.

Cirin Hattar have applied for the renewal of the registration of “Zepsin (Famotidine) 10mg Suspension” (Reg. No.

027295). During the scrutiny, he observed that the above mentioned product had been registered in the name of M/s. Cirin

Pharmaceuticals Hattar through toll manufactured by M/s. Bloom Pharmaceuticals Hattar. He has therefore forwarded the

case for further action. The initial date of registration of the drug is 09-05-2002. The permission is expiring on 08-05-

2007. They have deposited fee of Rs. 4000/- for this purpose.


Case No. 6.

The DDC (RRR) has forwarded the case of M/s. Surge Laboratories Sheikhupura wherein he has informed that

M/s. Surge Laboratories have applied for the renewal of the registration of following products:-

S. No. Name of the Drugs Reg. No. Initial date of Registration.

Toll permission validity.

1. Yaljpram Tablets 20mg

(Citalopram as HBr)

024330 14-03-2002 13-03-2007

2. Romycin Capsules 250mg

(Azithromycin dihydrate USP eq. To Azithromycin base ......... 250mg)

024331 -do- -do-

3. Romycin Suspension 200mg

(Azithromycin dihydrate USP eq. To Azithromycin base ......... 200mg)

024332 -do- -do-

4. Comport Syrup 5mg

(Loratadine .. 5mg)/5ml

027708 04-05-2002 03-05-2007

5. LPZ-15 Capsules

(Lansoprazole)

027709 -do- -do-

6. LPZ-30 Capsules

(Lansoprazole)

027710 -do- -do-

7. Comport Tablet 10mg

(Loratadine .. 10mg)

027707 -do- -do-

During the scrutiny, he observed that the above mentioned product had been registered in the name of M/s. Surge

Laboratories Sheikhupura through toll manufacturing by M/s. Nabiqasim Industries Karachi. They have deposited fee of

Rs. 4000/- for this purpose.


Case No. 7.

The DDC (RRR) has forwarded the case of M/s. Wilshire Laboratories Lahore wherein he has informed that M/s.

Wilshire Laboratories have applied for the renewal of the registration of following products:-

S. No. Name of the Drugs Reg. No. Initial date of Registration. Toll permission validity.

1. Amoni Syrup

(Ammonium Chloride .... 100mg

Sodium Citrate ................ 58mg

Chlorpheniramine Maleate .. 2mg)/5ml

028772 27-09-2002 26-09-2007

2. Nydrazide Syrup

(Isoniazid ....... 50mg)/5ml

028773 -do- -do-

3. Wilfen Suspension

(Ibuprofen .......... 100mg)/5ml

028774 -do- -do-

During the scrutiny, he observed that the above mentioned product had been registered in the name of M/s.

Wilshire Laboratories through toll manufactured by M/s. Mian Brothers Lahore.


Case No. 8.

The DDC (RRR) has forwarded the case of M/s. Dr. Raza Pharma Peshawar wherein he has informed that the

firm have applied for the renewal of the registration of following products:-

S. No. Name of the Drugs Reg. No. Initial date of Registration.

Valid up to.

1. Ceph-1 Injection 500mg

(Cephradine)/vial

027727 03-05-2002 02-05-2007

2. Ceph-1 Injection 1gm

(Cephradine)/vial

027726 -do- -do-

During the scrutiny, he observed that the above mentioned product had been registered in the name of M/s. Dr.

Raza Pharma Peshawar Hattar through toll manufactured by M/s. Medicaids Karachi.


Case No. 9.M/s. Gray's Pharmaceuticals Islamabad have informed that they were granted the registration of following

products through toll manufacturing by M/s. Ipram International Islamabad for a period of one year up to 9th May,

2007:-

S. No. Name of the Drug(s) Reg. No. Initial date of registration.

1st permission Toll permission

validity.

1. Medoxin 250mg Injections IM/IV

Each vial contains:-

Cefotaxime Sodium eq.

to Cefotaxime ...................250mg

031929 10-12-2003 10-05-2006 09-05-2007

2. Medoxin 500mg Injections IM/IV



to Cefotaxime ...................500mg

031930 -do- -do- -do-

3. Medoxin 1gm Injections IM/IV



to Cefotaxime ..................... 1gm

031931 -do- -do- -do-

4. Ne-Zone 250mg Injections IM/IV


Ceftraixone Sodium eq.

Ceftraixone ..................... 250mg

031932 -do- -do- -do-

5. Ne-Zone 500mg Injections IM/IV



Ceftraixone .................... 500mg

031933 -do- -do- -do-

6. Ne-Zone 1gm Injections IM/IV



Ceftraixone ..................... 1gm

031934 -do- -do- -do-

7. Gratin 250mg Injections IM/IV


Ceftazadime (as Pentahydrate)

...... 250mg

031936 -do- -do- -do-

8. Gratin 1gm Injections IM/IV


Ceftazadime (as Pentahydrate)

.............1gm

031937 -do- -do- -do-

9. Grizone 250mg Injections


Cefoperazone Sodium eq. To

Cefoperazone .......... 250mg

031938 -do- -do- -do-

10. Grizone 1gm Injections


Cefoperazone Sodium eq. To

Cefoperazone ............. 1gm

031939 -do- -do- -do-

11. Tiobine 50mg Injections

Each 2ml contains:-

Ranitadine (as Ranitidine HCl)

........... 50mg

031940 -do- -do- -do-

They have requested for extension in toll manufacturing permission.

Decision: The Board decided to grant one year extension of toll manufacturing. This extension will be final and the firm is

required to submit the progress report after six months about the construction of their manufacturing facility. The firm will

submit undertaking on stamp paper that they will not seek further extension for toll manufacturing.

Case No. 10.

M/s. Xenon Pharmaceuticals (Pvt.) Ltd; Lahore have informed that they were granted the registration of following

products through toll manufacturing by M/s. Mass Pharma Lahore:-

S. No. Name of Drug(s) Reg. No. 1st permission for toll manufacture

2nd permission for toll manufacture

1. Cefkan SuspensionEach 30ml contains:-Cefixime………600mg

029382 19 May 2003 to 18 May 2006

Approved in 200th

meeting for one year.

2. Vetrox Injection 250mgEach vial contains:-Ceftriaxone Sodium eq. to Ceftriaxone…………250mg

029383 -do- -do-

3. Vetrox Injection 500mgEach vial contains:-Ceftriaxone Sodium eq. to Ceftriaxone…………500mg

029384 -do- -do-

4. Vetrox Injection 1gmEach vial contains:-Ceftriaxone Sodium eq. to Ceftriaxone…………1gm

029385 -do- -do-

It is submitted that the Drugs Registration Board in 200 th meeting approved the extension of above products for

one year subject to submission of undertaking on stamp paper that the firm will not seek any further extension. The firm

was asked to submit undertaking so that the extension letter may be issued but they did not submit that. However as per

telephonic discussion with CEO of M/s Xenon Pharma the firm was getting the products manufactured by M/s Mass

Pharma during last year.


Case No. 11.

M/s. Leads Pharma Islamabad have informed that they were granted the registration of following products

through toll manufacturing by the firms mentioned against each. Details are as below:-

S.No. Name of drugs Reg. No. To be toll Manufactured

by.

1st permission for toll

manufacturing

2nd permission for toll manufacturing

1Levocin 250mg Tablets(Levofloxacin)

035878 M/s Mass Pharma Lahore

10-01-2005 to09-07-2005

01-06-2006 to31-05-2007

2Levocin 500mg Tablets(Levofloxacin)

035879 -do- -do- -do-


by.


manufacturing


3Ratadil 10mg Tablets(Loratadine)

035889 -do- -do- -do-

4Flurle 100mg Tablets(Flurbiprofen)

035893 -do- -do- -do-

5Ceftrol 250mg Injection(Ceftriaxone)

035896 -do- -do- -do-

6Ceftrol 500mg Injection(Ceftriaxone)

035897 -do- -do- -do-

7Ceftrol 1000mg Injection(Ceftriaxone) 035898

-do- -do- -do-

8Futazim 250mg Injection(Cefotaxime)

035899 -do- -do- -do-

9Futazim 500mg Injection(Cefotaxime)

035900 -do- -do- -do-

10Futazim 1gm Injection(Cefotaxime)

036301 -do- -do- -do-

11Cytamic 500mcg Injection(Mecobalamine)

036302 -do- -do- -do-

12Omeral 20mg Capsules(Omeprazole)

036303 -do- -do- -do-

13Lefox 250mg Tablets(Ciprofloxacin)

035880 M/s. Global Islamabad.

-do- -do-

14Lefox 500mg Tablets(Ciprofloxacin)

035881 -do- -do- -do-

15Leceph 250mg Capsules(Cephradine)

035882 -do- -do- -do-

16Leceph 500mg Capsules(Cephradine)

035883 -do- -do- -do-

17Leceph 125mg SuspensionCephradine 125 mg/5ml

035884 -do- -do- -do-

18Leceph 250mg SuspensionCephradine 250 mg/5ml 35885

-do- -do- -do-

19Leceph 500mg Injection(Cephradine)

035886 -do- -do- -do-

20Klaricil 250mg Tablets(Clarithromycin)

035887 -do- -do- -do-

21Klaricil 500mg Tablets(Clarithromycin)

035888 -do- -do- -do-

22Leazole 30mg Capsules(Lansoprazole)

035891 -do- -do- -do-


by.


manufacturing


23Penapol 40mg Tablets(Pantaprozole)

035892 -do- -do- -do-

24Azimik 250mg Capsules(Azithromycin)

035894 -do- -do- -do-

25Azimik 200mg Suspension(Azithromycin)

035895 -do- -do- -do-

They have further informed that the previous permission is going to expire on 31st May, 2007 and 90% work has

been completed and the delay is only due to following reasons:-

1. Imported machinery which has been delayed from their principal supplier and their one Alu/Alu blister machine is

still on the way.

2. Secondly the delay is due to their electric work that is in process and would be completed within 03 to 04 months.

They are changing their internal and external wiring because their electric load had been increased and installation

of new transformer and generator.

They have therefore, requested to granted them further extension in toll manufacturing permission. The firm has

not deposited any fee for this purpose.

Decision: The Board decided to grant extension of toll manufacturing for 3 months. This extension will be final and the

firm is required to submit the progress report after six months about the construction of their manufacturing facility. The

firm will submit undertaking on stamp paper that they will not seek further extension for toll manufacturing.

Case No. 12.

M/s. Medico International Services (Pvt.) Ltd; Peshawar were granted the registration of “Duoton T.P. Capsules”

(Reg. No. 015786) through toll manufacturing by M/s. Bloom Pharmaceuticals (Pvt.) Ltd; Hattar and the permission has

expired on 21-03-2007. They want to continue the manufacturing of this product through toll manufacturing by M/s.

Bloom Pharmaceuticals (Pvt.) Ltd; Hattar.

They have deposited fee of Rs. 8000/- for this purpose and have requested for extension in toll manufacturing

permission. It is submitted that the product was initially registered on 22-03-2002 for a period of 03 years till 21-03-2005.

The Registration Board in its 178th meeting unanimously decided to extend registration period of such drugs to its normal

period of 05 years. It is also informed that M/s. Bloom Pharmaceuticals Hattar have no HVAC.

Decision: The Board decided to grant one year extension of toll manufacturing subject to the change of the manufacturer

which has hormone capsule section. This extension will be final and the firm is required to submit the progress report after

six months about the construction of their manufacturing facility. The firm will submit undertaking on stamp paper that

they will not seek further extension for toll manufacturing.

Case No. 13.

ADC (I & E) has forwarded a letter wherein he has informed that allocation of Quota to the following firms

having registration of formulation of drugs containing Codeine Phosphate has been held in abeyance from the end of the

last year due to clarification as to whether the formulation of these firm are rational or otherwise.

The details are as under:-

S. No. Name of the Firm Name of the Drug(s) Reg. No. Remarks.

1. M/s. Abbott Laboratories (Pakistan) Ltd; Karachi

Brucodin Tablets(Ibuprofen .................200mgCodeine Phosphate ... 20mg)

044415 Appellate Board in its 124th sitting accepted the formulation containing Ibuprofen 200mg and Codeine phosphate 20mg per tablet instead of applied Ibuprofen 400mg and Codeine phosphate 30mg per tablet.

2. M/s. Perfect Pharma Lahore.

Coldapin Tablets(Paracetamol ............ 500mgCodeine Phosphate .... 15mgCaffeine ....................15mg)

032918

3. M/s. Syntex Pharmaceuticals Attock.

Synadoc Tablets(Paracetamol ............ 500mgCodeine Phosphate .... 15mgCaffeine.................... 30mg)

040271

4. M/s. Pharmedic Laboratories (Pvt.) Ltd; Lahore.

Codoprim-C Tablets(Codeine Phosphate ... 15mgCaffeine .................... 15mg)

028653

5. M/s. Wilson's Pharmaceuticals Islamabad.

Codogesic tablets(Codeine Phostate ...... 15mgParacetamol ............ 500mg

028966

Decision: The Board decided to defer the case to collect more information.

Case No. 14.

Registration Board in its 198th meeting has approved General Tablet Section with HVAC of M/s. Medera

Pharmaceuticals (Pvt.) Ltd; Islamabad. Following products were considered in the 200 th meeting of the Registration Board

and were deferred for the submission of the progress report of the already registered drugs. The firm have submitted the

samples of their 21 already registered products. Following are the pending products for grant of registration:-

S. No. Name of Drug(s) Pack Size

Price

1.Azera Tablets 250mgEach tablet contains:Azithromycin (as dihydrate) …….250mg

1x10’s -do-

2.Azera Tablets 500mgEach tablet contains:Azithromycin (as dihydrate)…….500mg

1x10’s -do-

3.Medflox Tablets 400mgEach tablet contains:Pefloxacin (as Mesylate) ………. 400mg

10’s -do-

4.Levoxin 250mg TabletsEach tablet contains:Levofloxacin (hemihydrate) ……250mg

10’s -do-

5.Levoxin 500mg TabletsEach tablet contains:Levofloxacin (hemihydrate) …..500mg

10’s -do-

6.Moxi TabletsEach tablet contains:Moxifloxacin………..400mg

1x10’s -do-

7.Spark TabletsEach tablet contains:Sparfloxacin……..100mg

1x10’s -do-

8.Cleria Tablets 250mgEach tablet contains:Clarithromycin……..250mg

1x10’s -do-

9.Cleria Tablets 500mgEach tablet contains:Clarithromycin……..500mg

1x10’s -do-

10.Erarox Tablets 150mg.Each Tablet Contains:-Roxithromycin............................150mg.

1x10's -do-

Decision:- The Board approved* the applications for registration subject to the satisfactory inspection report by the panel

of inspectors FID Islamabad , DDC (QC-II), ADC R-II (North).

Case No. 15.

M/s. Zesion Pharmaceuticals (Pvt.) Ltd; Islamabad have informed that they applied for the registration of

“Diclotol (Diclofenac Sodium + Misoprostol)” and the said application is pending due to technical reasons. They have

also applied for “Alfacal (Alfacalcidol) 0.25mcg Tablets” in that meeting which is pending also.

They have therefore, requested to grant them the registration of the said product instead “Diclotol tablets”.

Decision: - Approves* subject to submission of product content uniformity before marketing.

Case No. 16.

M/s. Highnoon Laboratories Ltd; Lahore have requested for registration of following pending

product:-

S. No. Name of Drugs/Label Claim. Pack Size Price. Remarks

1. Elzim 10/10 TabletsEach tablet contains:-Ezetimibe ........................ 10mgSimvastatin ........................ 10mg

10's Rs.525.00 Approved* subject to renewal of

the license of the firm


10's Rs.716.00 -do-


10's Rs.907.00 -do-


10's Rs.1602.00 -do-

Case No. 17.

M/s. Vision Pharmaceuticals Islamabad have requested for registration of following product:-

Albendol SuspensionEach 5ml contains:-Albendazole U.S.P. ................ 200mg

Decision: The application was approved* for registration.

Case No. 18.

M/s. Guyton Pharmaceuticals Lahore have requested for grant of additional pack of already registered

product “Guycin registration”. The drug was registered with following formulation while the firm has applied Amikacin

(as Sulphate)…100mg per 2ml.

042990 Guycln InjectionEach ml contains:-Amikacin (as Sulphate)…50mg

Decision: The application was approved* for registration.

Case No. 19.

M/s. Himont Pharmaceuticals (Pvt.) Ltd; Lahore have requested for the registration of following product:-

Pamaryl Plus TabletsEach tablet contains:-Glimepride ...........................1mgMetformin HCl ................ 500mg


.Case No. 20.

M/s. Candid Pharmaceuticals Lahore have informed that they want to de-register following

products:-


1. Malayrex Tablets(Pyrimethamine ........ 25mgSulfadoxine ................ 500mg

022335

2. Candizole-M Tablets(Furazolidone ........ 300mgMetronidazole........ 100mg

022334

They have requested to register following products on fast track basis instead of above mentioned products:-


1. Medivit TabletsEach tablet contains:-Vit. A......................... 2400iμVit.B1 ............................... 2.5mgVit.B2 ............................... 2.5mgVit.B6 ............................... 1.0mg

2x10's Rs. 184.00


Vit.B12............................. 4.9mcgVit.C ................................. 40mgVit.D ................................. 240iμVit.E .................................. 2mgNicotinamide ................... 20mgCalcium pantothenate ......... 10mgLecithin ............................... 9.5mg

2. Gabex CapsulesEach capsule contains:-Gabapentin sodium .................. 100mg

10's Rs. as per SRO

Decision: The Board approved drugs for de-registration and deferred the applications for registration of Vitamins for

policy.

Case No. 21.

M/s. Unexolabs (Pvt.) Ltd; Lahore have informed that they want to de-register their following products:-

S. No. Name of the Drugs Reg No.

1. Sulquine Tablets. 008785

2. Paracetamol Compound tablets. 003526

They have requested to register their following products on fast track basis instead of the above

mentioned products:-


1. Euga-50 TabletsEach tablet contains:-Suldenafil as Citrate ..................... 50mg

6's Rs. 344.00 Not on Form-5 D

2. Euga-50 TabletsEach tablet contains:-Suldenafil as Citrate ..................... 50mg

6's Rs. 605.00 Not on Form-5 D

Decision: The Board approved drugs for de-registration and rejected the applications for registration as the said

applications are not on form 5-D.

Case No. 22.

M/s. English Pharmaceuticals Lahore have requested to register their following products on fast track

basis in place of two registered drugs which they want to surrender:-

S. No. Name of Drugs/Label Claim. Pack Size

Price. Products to be De-registered

1. Efactum 1gm InjectionsEach Injection contains::-Ceftriaxone ............................ 500mgSulbactum .............................. 500mg

1's As per SRO Utofen Capsule 100mg(Ketoprofen)(Reg. No. 029010)

2

Efactum 2gm InjectionsEach Injection contains::-Ceftriaxone .............................. 1gmSulbactum .............................. 1gm

1's As per SRO Utofen Capsule 200mg SR(Ketoprofen)(Reg. No. 029011)

Decision: The Board approved drugs for de-registration and rejected the applications for registration as the said

applications are not on form 5-D.

Case No.23

The mentioned below firms have applied for the De-Registration of following drugs in place of Fast Track

drug applications.

Name of the firm Brand name/Label claim Registration No.

M/s Mac & Rains,Lahore

Asthamac SyrupAcefylline piperazine

041436

-do- Fevol SuspensionParacetamol suspension

041441

M/s Valor Pharmaceutical, Islamabad.

Vasprin Registration. 027893

M/s Neutro Pharma, Lahore Bazole Suspension 038874

-do- Lolrphine Syrup 038875

-do- Resti Suspension 038869

-do- Khusmol Suspension 038873 -do- Metoca Suspension 038880

-do- Kite Injection 10ml 022641

-do- Cyanocob Injection 1ml 038833

-do- Netigmine Injection 1ml 038831

-do- Benate Injection 1ml 044617

M/s CCL, Lahore. Ulcet Tablets 200mg. 011022

Decision: The Board approved the drugs for de-registration.

Case No. 24.

M/s. Global Pharmaceutical has applied for the De-Registration of their products in the Eye Preparation

Section (The Whole Section) and Sachet Filling Section. The firm has applied for the De-Registration of 22 products in

the above two sections and has applied fast track registration of 29 products in place of these products.

The Board approved the following drugs for de-registration.

S. No. Brand Name/Label Claim. Reg. No.

1. Artinil Eye Drops.

Diclofenac Sodium.....................1mg.

030552

2. Dicon Eye Drop.

Tobramycin ....................300mg.

Dexamethasone ..............100mg.

017489

3. Dicon-N Eye Drops.

Dexamethasone Phosphate..........1mg.

Neomycin...........................3.5mg

030549

4. Ketolerg Eye Drops.

Ketotifen (Fumarate)...................0.5mg

030543

5. Lubri Plus Eye Drops.

Polyvinyl Alcohol.............14mg.

030544

6. Lubri Plus Eye Drops.

Polyvinyl Alcohol..............14mg

030545

Povidone........................6mg.

7. Methlon Forte Eye Drops.

Flourometholone ..........0.25%

030546

8. Methlone Eye Drops.

Flourometholone...............1mg

030547

9. Methlone N Eye Drops

Flourometholone.................1mg.

Neomycin.........................3mg.

030548

10. Nafcin Eye Drops.

Ciprofloxacin....................3mg.

034021

11. Ofloquin Eye Drops.

Ofloxacin.........................3mg.

030550

12. Oradium Eye Drops.

Sulphacetamide Sodium.......20%

036169

13. Levolol Opthalmic Solution.

Levobunolol.......................5mg.

030523

14. Hydero Gentin Ear Drops.

Gentamycin.......................3mg.

Hydrochortisone.............10mg.

036168

15. Vestogen Eye Drops.

Gentamycin.....................3mg.

034022

16. Bssan Drops.

Betamethasone. + Neomycin

038419

17. Supraphen Eye Drops.

Chloramphenicol.............5mg.

034023

18. Flrobex Eye Drops.

Flurbiprofen................300mcg

030551

19. Femocal Plus Sachet. 030521

20. Femocal Sachet. 030520

21. Glucolyte Sachet. ORS. 025924

22. Mecomx Sachet. 030522

Mecobalamin...............500mcg.

Products Applied for Fast Track-Registration by M/s. Global Pharmaceuticals, Islamabad.

S. No. Brand Name/ Label Claim Pack Size. Proposed Price. Decision.

1. Gimicin Tablets.

Each Tablet Contains:-

Gemifloxacin as Mesylate eq to Gamifloxacin..........320mg

7's Rs. 830.00 Approved*

2. Glotek Tablets.


Telithromycin.....400mg.

10's Rs. 630.00 -do-

3. Silimine-C Tablets.


Silymarin................300mg

Ascorbic Acid.......500mg.

10's As fixed by the Govt.

Rejected as the Drug is not approved in

FDA/ and the firm did not apply on Form -D.

4. Gabpan Tablets.


Gabapentin.............800mg.

10's -do- Approved*.

5. Phusilan Tablets.


Sodium Fucidate...250mg.

10's -do- -do-/ change of name.

6. Artinil-KM Tablets.


Diclofenac Potassium.....50mg.

Misoprostol.........200mcg.

10's -do- Rejected due to wrong reference of me-too product/Not applied

on Form 5-D/ the drug is not FDA approved.

7. P-Cyclo Tablet.


Piroxicam as Betacyclodextrin.....20mg.

2x10's -do- Approved*.

8. Bonish Tablets.


Ibandronate as Sodium..............150mg

1's -do- Rejected because the firm submitted the

Form-5 D but actually the details are of

Form-5.

9. Glorid Tablets. 10's -do- Approved*


Itopride Hcl........50mg.

10. Moxicin Tablets.


Moxifloxacin .......400mg.

10's Rs. 630.00/ 5 Tablets.

-do-

11. Telsartan Tablets.


Telmisartan...........80mg.

3x10's As fixed by the Govt.

-do-



Telmisartan...........40mg.

3x10's -do- -do-



Telmisartan............20mg.

3x10's -do- -do-

14. Razole Tablets.


Rabeprazole as Sodium....20mg

10's -do- -do-

15. Razole Tablets.


Rabeprazole as Sodium....10mg

10's -do- -do-

16. Glovir Tablets.


Acyclovir.......................800mg.

10's -do- -do-

17. Glovir Tablets.


Acyclovir.......................200mg.

10's -do- -do-

18. Citolin Tablets.


Citicolin Sodium............200mg.

10's -do- -do-

19. Citolin Tablets.


Citicolin Sodium............500mg.

10's -do- -do-

20. Glite-F Tablets.


Pioglitazone..................15mg.

Metformin Hcl.............500mg.

10's -do- -do-

21. Glite-DF Tablets.


Pioglitazone..................15mg.

Metformin Hcl.............850mg.

10's -do- -do-

22. Glite Tablets.


Pioglitazone as Hcl..........45mg.

10's -do- -do-

23. Glite Tablets.


Pioglitazone as Hcl..........30mg.

10's -do- -do-

24. Glovir Tablets.


Acyclovir...................400mg.

10's -do- -do-

25. Tamsol Capsule.

Each Casule Contains:-

Tamsulosin Hcl.............0.4mg

3x10's -do- Rejected as the firm did not apply on Form

5-D/ product is in delayed release dosage

form but the firm applied for plain

capsules.

26. Gabpan Capsules.

Each Capsule Contains:-

Gabapentin....................600mg.

10x10's -do- Rejected as the firm did not apply on form

5-D.

27. Imclas Injection IV.

Each Vial Contains:-

Imipenem as Monohydrate...........500mg

Cilastatin as Sodium......500mg

1's -do- Approved*

28. Profol Injection IM/IV.

Each ml Contains:-

Propofol.........................10mg.

1's -do- Deferred for obtaining the source of Raw

material from the firm.

29. Toxirid Injection IV. 1's -do- Approved*.

Each Vial Contains:-

Cefoperazone as Sodium.............250mg

Sulbactam as Sodium.....250mg

Case No. 25

M/s. Highnoon Laboratories has applied for extension in the toll manufacturing permission of the under

mentioned drugs. Details are as below:-

S.No. Name of Products Reg: No. Toll Manufacturer

Date of initial registration

First permission for toll.

2nd permission for toll.

1. Cefatil Injections 500mgEach Vial contains:- Cephradine…………500mg

015506 M/s, Surge Labs Lahore

06-06-1994 (Import)

13-01-2003 to 12-01-2006

30-06-2006 to 29-06-2007.

2. Cefatil Injections 1gmEach Vial contains:- Cephradine…………1 gm

009140 -do- 25-01-1987 (Import)

-do- -do-

3. Cyrocin Infusion(Ciprofloxacin)

011408 M/s. StandPharm Lahore

25-07-1990 -do- -do-.

The permission is expiring on 29-06-2007. Now the firm has again requested for extension in contract

manufacturing permission of the aforesaid products. They have deposited the fee of Rs.8000/- each for this purpose.

Decision: The Board decided to grant one year extension of toll manufacturing subject to the change of manufacturers.

This extension will be final and the firm is required to submit the progress report after six months about the construction

of their manufacturing facility. The firm will submit undertaking on stamp paper that they will not seek further extension

for toll manufacturing.

Case No. 26.

M/s. Navegal Pharmaceuticals applied for transfer of registration of following drugs from toll manufacturing to

their premises as they have established their facilities. The case was discussed in 204th meeting and was deferred for

installation of HVAC:-


1. Naveten 1mg Tablets (Ketotifen)

015732

2. Piram 20mg Capsules (Piroxicam)

015731

3. Zanidon 150mg Tablets (Rinatidine as HCl)

018979

Now the firm has informed that they have installed HVAC System in tablet section.

Decision: The request of the firm was acceded to.

Case No. 27.

M/s. Pharmacare Laboratories (Pvt.) Ltd; Lahore have informed that they were applied for their products "Lohist

Syrup & Diloxazole Suspension" (Reg. No. 032371 & 032372) through contract manufacturing from M/s. Ideal

Pharmaceuticals Industries Lahore. But the registration letter was issued without mentioning the name of the toll

manufacturer. They have requested to issue the corrigendum/correction in Registration Letter.

As per Minutes of the 180th-A Meeting of Me-Too committee name of the Toll manufacturer is missing. M/s.

Pharmacare Laboratories (Pvt.) Ltd; Lahore have informed that they have no facility to manufacture Liquid Preparations.

They had applied for their products "Lohist Syrup & Diloxazole Suspension" (Reg. No. 032371 & 032372) through

contract manufacturing by M/s. Ideal Pharmaceuticals Industries Lahore. But the registration letter was issued without

mentioning the name of the toll manufacturer.

It is submitted that the registration letter was issued in 26th March, 2004.


Case No. 28.

The Drugs Registration Board in its 202nd meeting decided to reject the following applications of M/s. Himont

Pharmaceuticals Lahore and to issue show cause notice to the firm as it was noticed that the firm has applied for the

registration of drugs of which it already has registration with different brand names

Name of the Product Demanded

Pack

Demanded

Price

Already

Registered

Drugs

Iroplex Tablet 16’s Rs. 80 Ferplex Tablet

Each tablet contains:

Iron Protein Succinylcasein eq. to

trivalent iron……………….20 mg

Irplex Plus Tablet

Each tablet contains:

Iron Protein Succinylate…..400 mg

Folic Acid…………………..2.5 mg

16’s Rs. 190.91 Ferplex Plus

Tablet

Iroplex Syrup

Each 15 ml contains:

Iron Protein Succinylate…..800 mg

1’s Rs. 118.4 Ferplex Syrup

The firm has replied to the show cause notice and informed that the registration of said products was requested in

the name of M/s. Square Pharmaceuticals (Pvt.) Ltd; their sister concern for third party manufacturing. According to them

they have not violated the Drug Act 1976. The have further informed that they have invested huge amount in the transfer

of technology and establishment of a brand new manufacturing facility to only save foreign exchange but also to create

new job. They have therefore, requested to consider their request for registration.

Decision:- The Registration Board up hold is previous decision to reject the applications.

Case No. 29.

The Registration Board in its 176 th meeting held on 31st October & 1st November, 2002 had deferred the

decision on registration of “Anatet Injection” (Purified Tetanus Toxoid) (Vaccines) of M/s. Amson Vaccines & Pharma

(Pvt.) Ltd; Islamabad for biological Committee.

M/s. Amson Farmaco

Biologico, Islamabad

Anatet InjectionEach ml contains:-Purified Tetanus Toxoid….20Lf+2LfAluminium Phosphate

Single dose1x10’s1x20’s

10 dose vial

Rs.32.00Rs.320.00Rs.640.00Rs.288.00

Deferred for biological committee.

ADC (Reg-I) has furnished the extract from the Minutes of 14th Meeting of the expert Committee on Biological Drugs

held on 20/03/2004. The Committee has recommended the said product.

It is submitted that Amson Pharma Islamabad is already marketing the following brands:-

Anatetall Injection (Chiron Biocine)Each dose contains:- Adsorbed Toxoid Toxoid…40 IU(Regn.No.013277)

10 x 1 doses Rs.297.00

Imatet Injection Each 0.5 dose contains:-

(Tray pack) 10 x 1Dose(Blister pack) 1 Dose

Rs.319.00Rs.32.25

Adsorbed Tetanus Toxoid…40 IU(Imported in bulk concentrate and manufactured locally)

(Blister pack) 10 x 1’s Rs.322.50

The case was in 200th meeting and decided as under:-

“The firm will be asked to submit justification for application for registration of drug already registered in their name with

different brand name”.

In reply the firm has informed that “Anatet Injection” is registered in the name of M/s. Majeedsons

Rawalpindi and they applied for transfer of registration form import to bulk import and local repacking by M/s. Amson

Vaccine and Pharma. Ministry of Health asked to provide consent of foreign manufacturer. M/s. Majeedsons Rawalpindi

could not provide it as the foreign manufacturer refused. M/s. Majeedsons informed that another manufacturer is ready to

give us such consent.

Decision:- The request of the firm was rejected.

Case No. 30.

On complaint of M/s. Efroze Chemical Industry (Pvt.) Ltd; Karachi M/s. Qintar Pharmaceuticals Sargodha was

asked to change their brand name of drugs “Mefnex 250mg Tablets and Mefnex DS Tablets 500mg” (Reg. No. 030674 &

030648) which have resemblance/similarity with the brand name “Mefnac 250mg & 500mg” (Reg. No. 00481 & 011270)

of M/s. Efroze Chemical; Industries (Pvt.) Ltd; Karachi. But on repeated reminders the firm refused to change the name

and and gave its reasons for not to change the name.

The case was discussed in 200th meeting of the Board and the Board decided to issue the show cause notice to the

firm. The firm in reply to the show cause has expressed its view point as follows.

That both the products meaning thereby Mefnax & Mefnax DS (Mefnamic Acid) 250mg & 500mg Tablets” of the

appellant and Mefnac & Mefnac DS (Mefnamic acid) 250mg & 500mg of M/s. Efroz Chemical Industries (Pvt.) Ltd; are

similar in nature, so there is no difference /apprehension of harm attached to the patient as once the Doctor may prescribed

one and if the Druggist handed over other , because the nature/chemical of both the drugs are same as both are pain killer.

By keeping this thing in juxta position that the primary function of the Ministry is to watch the interest of the Public

whereas in the present scenario and the given circumstances the matter in hand only commercial in nature.

That drug in question was registered with the Ministry on 23-8-2003 meaning thereby three years back and during

the course of business it is needless to mention here as it should be taken as an admitted fact that the Appellant had spend

a huge quantity of bulk of its promotion material also in store, therefore, the change of name in present situation show

cause a sir-repairable / irrecoverable loss to the appellant.

That as well the issue of resemblance in both the products are concerned, it is submitted with utmost humbleness

that apparently there is no similarity or resemblance between the two names of the products because the spelling, the

pronunciation are very clear and very fact further strengthen from the fact not a single complaint ever registered either

from the Doctors or from the Druggist or from, the patients for three years.

That retail price is approximately same and infect the Appellant is providing/manufacturing comparatively a

better quality with regular and high started promotive efforts.

They have therefore, requested to reverse the show cause notice in favour of M/s. Qintar Pharmaceuticals,

Sargodha. The Registration Board in its 204th meeting decided to call the M/s. Qintar Pharmaceuticals, Sargodha for the

personal hearing. The firm was called for Personal hearing. Mr. Azhar Hussain of M/s Qintar pharma Sargodha appeared

before the boards and presented his case.

Decision: - M/s. Qintar Pharmaceuticals was agreed to change their brand name. The firm was advised to propose new

brand name within two weeks.

Case No. 31.

M/s Aneeb pharmaceuticals Lahore have applied for registration of following products.

S. No. Brand Name/Label Claim. Pack Size. Demanded MRP

Decision

1. Oflex Tablets.Each Tablet Contains:-Ofloxacin as HCl USP………200mg.

1x10’s Rs.95.00 Approved*

2. Ciprocin Tablets.Each Tablet Contains:-Ciprofloxacin as HCl USP….250mg.

1x10’s Rs.105.00 -do-

3. Ciprocin-DS Tablets.Each Tablet Contains:-Ciprofloxacin as HCl USP….500mg.

1x10’s Rs.215.00 -do-

4. Anobex Tablets.Each Tablet Contains:-Levofloxacin………………..250mg.

1x10’s Rs.250.00 -do-

5. Anobex-DS Tablets.Each Tablet Contains:-Levofloxacin………………..500mg.

1x10’s Rs.400.00 -do-

Case No. 32

M/s. Alen Pharmaceuticals (Pvt.) Ltd; Risalpur have informed that they want to change their toll manufacturer

from M/s. Welwrd Pharmaceuticals to M/s. Welmark Pharmaceuticals for their following products:-

S. No. Name of the Drug(s) Reg. No.

1. Alencef 250mg Injections

(Cefotaxime)

044406


(Cefotaxime)

044407

3. Alencef 1gm Injections

(Cefotaxime)

044408

They have not deposited any fee for this purpose. It is submitted that M/s. Welmark was granted License in 203rd

meeting and their application for registration were approved in 206th meeting.

Decision: - The board advised the firm to change the manufacturer as M/s. Welmark pharmaceuticals is itself under the

phase of developing their own products.

Case No. 33. The Drugs Registration Board in its 200th meeting granted extension in toll manufacturing of following

drugs of M/s. Nevegal Pharmaceuticals Hattar for 01 year and to submit undertaking on stamp paper that they will not

seek further extension for toll manufacturing.

S. No. Name of Drug(s) Reg. No. Name of toll manufacturer

1. Ceftium 1gm IV (Ceftriaxone Sodium) 021086 M/s. Welwrd

Pharmaceutical

Hattar.

2. Ceftium 250mg IV (Ceftriaxone Sodium) 020484 -do-

Under the current toll manufacturing policy M/s. Welwrd Pharmaceutical Hattar was already granted 50

registrations to manufacture for others. M/s. Navegal was advised to change the manufacturer. Now M/s.

Welwrd has informed that they want to surrender following products granted to be manufactured for M/s. Alen

Pharmaceutical Risalpur and toll extension letter for M/s. Navegal may be issued.



(Cefotaxime)

044406


(Cefotaxime)

044407

3. Alencef 1gm Injections 044408

(Cefotaxime)

Decision: - The request of M/s. Welwrd Pharmaceuticals to surrender M/s Alen’s products was acceded to and to issue

extension letter of M/s. Navegal Pharmaceuticals, Hattar.

Case No.34

Following product of M/s. Schazoo, Laboratories was approved in 201st meeting of me-too committee.

Neurotec Tablets.Each tablet contains:-Citicoline (as Sodium)………….500mg.

10’s Rs. 150.00/Tablet

It has been found that the product was not me-too product and was approved because the firm has quoted the me-

too reference of “Citolin Tablets” of M/s Global Pharmaceutical, Islamabad. But it has been found that the “Citolin

Tablets” are not registered and the firm has quoted the wrong reference of the me-too status of the product.

Decision:- The board up holded its previous decision however it was decided to issue a warning letter to the firm for the submission of wrong information.

Case No.35

M/s. Paktex Industries Manufacturer of Surgical Dressings, Kamoke have applied for renewal of registration of

their product "Cotton Bandages B.P. Type II" (Reg: No. 016607) after laps of grace period of sixty days. The DDG (R)

has advised them to apply a fresh for re-registration of the said product as well as of their product "Cotton Bandages B.P.

Type III" (Reg: No. 016608) as the date of initial registration of both the products is the same i.e. 02-02-1995.

Now the firm has submitted photocopy of application along with a copy of treasury challan of Rs. 8000/- for re-

registration of "Cotton Bandages B.P. Type II" (Reg: No. 016607) only.

The case was forwarded to Renewal Section for DML status. DDG (L & A) return the case with the remarks that

the renewal is due since 6th February, 2006. Panel of inspection has been conveyed to DDG (L & A) last year and report is

still awaited.


Case No.36.

The DDC (RRR) has forwarded the case of M/s. Tread Pharmaceuticals Pakistan (Pvt.) Lahore wherein he has

informed that the firm has submitted renewal application for following products:-

S. No. Name of the Drug(s) Reg. No. Initial Reg.

(Import)

Transfer from import to toll.

1. Etibi InjectionsEach 5ml contains:-Ethambutol di-HCl ...... 500mg

015536 1993 15-06-2002 to

14-06-2007

2. Anifed Retard TabletEach film coated tablet contains:-Nifedipine ................. 20mg

014005 -do- -do-

3. Pentafen InjectionsEach ml contains:-Pentazocine Lactate ....... 30mg

015773 -do- -do-

4. Forgenac InjectionsEach 3ml contains:-Diclofenac Sodium ......... 75mg

015537 -do- -do-

He has noted that the above mentioned products had been registered in the name of M/s. Tread Pharmaceuticals

Pakistan (Pvt.) Ltd; Lahore through toll manufacturing by M/s. Harmann Pharmaceuticals (Pvt.) Ltd; Lahore.

Decision:- The request of the firm was deferred to get information regarding the source and quantities of import of raw

material of ethambutol and international availability of ethambutol injection.

Case No.37.

M/s. Tread Pharmaceuticals Pakistan (Private) Ltd; Lahore have informed that they are the allottee of the Sunder

Industrial Estate and they were granted the registration of following products:-


1. Stator Tablets(Atorvastatin ..... 20mg)

035951

2. Tansaar Tablets(Losartan Potassium)

095952

3. Kastol Tablets(Montelukast Sodium ..... 10mg)

035953

The registration of above products has been expired on 30-12-2006. Looking the ground realities regarding the

completion of the development infrastructure of Sunder Industrial Estate, the said construction could not be started as per

their plan. However they have planned to start their construction in March, 2007.

They have therefore, requested to grant them the extension in the period of toll manufacturing of the above

mentioned drugs for a period of one year.

It is submitted that the above products were registered in the name of M/s. Fynk Pharmaceuticals Lahore for a

period of two years which has been expired.

Decision:- The request of the firm was rejected as the applications are not on form 5 by the manufacturer and not

supported with fee.

Case No.38

Following firms have requested for transfer of registration of their following products from import to local toll

manufacturing as under:-

S. No. Name of Firm

Name of Drug(s) Reg. No. Date of registration

To be toll manufactured by

1. M/s. ACME Lahore

Esopra 20 TabletsEach tablet contains:-Esomeprazole ......... 20mg

035782 31-12-2004 M/s. Mass Pharma (Pvt.) Ltd; Lahore.

2. -do- Esopra 20 TabletsEach tablet contains:-Esomeprazole ......... 20mg

035781 -do- -do-

3. M/s. Tarrot

Lahore.

Diclo-Denk 50 TabletsEach tablet contains:-Diclofenac Sodium ................. 50mg

017491 02-07-07 M/s. Mass Pharma Lahore.

4. -do- Diclo-Deng 75 InjectionsEach 3ml ampule contains:-Diclofenac Sodium BP ............ 75mg

017490 -do- -do-

5. M/s. Combat Eurasian Lahore.

Ozone InjectionEach ml contains:-Naloxone HCl ........ 0.4mg

021979 14-12-1998 M/s. Global Pharmaceuticals

Islamabad.

6. -do- Diferine InjectionsEach ampoule contains:-

023138 02-03-1999 -do-

S. No. Name of Firm

Name of Drug(s) Reg. No. Date of registration


Difemerine HCl ...... 1mg

7. -do- Caster 150mg TabletsEach tablet contains:-Roxithromycin ...... 150mg

022669 04-12-1998 -do-

8. -do- Phenacin Injections 40mgEach 2ml contains:-Orphenadrine ....... 40mg

023169 09-03-1999 -do-

9. M/s. Thames Pharmaceuticals Multan

Rheumaden 20mg Capsules(Piroxicam)

020689 20-01-1998 M/s. Pulse

Pharmaceuticals

Lahore.

10. -do- Inhipump 20mg Capsules(Omeprazole)

020688 -do- -do-

Decision:- The registration board approved the drugs for transfer from import to local toll manufacture initially for one

year and its further extension for 1 & ½ year shall be extended on satisfactory progress report.

Case No.39.

The DDC (RRR) has forwarded the applications of M/s. Ferroza International Pharmaceuticals Lahore wherein

they have applied for extension in toll manufacturing permission of following drugs:-

S. No. Name of Drug(s) Reg. No. Initial Date of Reg.

Valid Up to.

1. Taxpro Injection I.M.Each vial contains:-Ceftriaxine Sodium eq. to Ceftriaxone ................ 250mg

024050 24-04-2002 23-04-2007

2. Taxpro Injection I.M.Each vial contains:-Ceftriaxine Sodium eq. to Ceftriaxone ................ 500mg

024051 -do- -do-

3. Taxpro Injection I.M.Each vial contains:-Ceftriaxine Sodium eq. to Ceftriaxone ................ 1gm

024052 -do- -do-

4. Taxpro Injection I.V.Each vial contains:-Ceftriaxine Sodium eq. to Ceftriaxone ........ 250mg

024053 -do- -do-

5. Taxpro Injection I.V.Each vial contains:-Ceftriaxine Sodium eq. to Ceftriaxone ........ 500mg

024054 -do- -do-

6. Taxpro Injection I.V.Each vial contains:-Ceftriaxine Sodium eq. to Ceftriaxone ................ 1gm

024055 -do- -do-

The firm has also requested change of manufacturer from M/s. Global Pharmaceuticals Islamabad to M/s. Mass Pharm

Lahore.

Decision: The Board decided to grant one year extension of toll manufacturing and change of manufacturer. This

extension will be final and the firm is required to submit the progress report after six months about the construction of

their manufacturing facility. The firm will submit undertaking on stamp paper that they will not seek further extension for

toll manufacturing.

Case No.40.

The DDC (RRR) has forwarded the case of M/s. Xenon Pharmaceuticals (Pvt.) Ltd; Lahore wherein he has

informed that the firm has applied for renewal of registration of following products:-

S. No. Name of the Drug(s) Reg. No. Initial date of Reg. Valid up to.

1. Xetaxime Injections 250mg(Cefotaxime)

028037 24-07-2002 23-07-2007

2. Xetaxime Injections 500mg(Cefotaxime)

028038 -do- -do-

3. Xetaxime Injections 1gm(Cefotaxime)

028039 -do- -do-

After observation he has noted that the products have been registered in the name of M/s. Xenon Pharmaceutical

Lahore through toll manufacturing by M/s. Mass Pharma Lahore.




Case. No.41.

FID Islamabad conducted the inspection of M/s. Benson Pharmaceuticals Islamabad and pointed out the firm

have registration of Hormonal products with out dedicated section. The firm was show caused as to why registration of

following drugs may not be cancelled.

S .No. Name of the Drug(s) Reg. No.

1. Womegen TabletsEach Tablet contains:-Conjugated Oestrogens..........0.625mg

021580

2. Womegen DS Tablets 021581

3. Redated TabletsEach Tablet contains:-Levonorgestrel USP................0.15mgEthinyloestradiol.....................0.03mg

021582

The firm has not responded to the show cause.

Decision:- The board decided to cancel the registration of hormonal products of M/s Benson Pharma.

Case No.42.

M/s. Don Valley Pharmaceuticals (Pvt.) Ltd; Lahore have informed that the Drugs Registration Board in its 201 st

meeting approved the registration of their product “Propol Capsules 500mg” subject to confirmation of dedicated area.

According to them the standard environmental conditions for the manufacturing of this product are as follows:-

Temperature Below 25C

Humidity 40% RH Max.

They are already manufacturing Propol Sachets under above conditions so dedicated area is available, where

environmental conditions are maintained by airconditionin and with Dehumidifier for the manufacturing of Propol

Capsules.

They have therefore, requested to issue the registration of “Propol Capsules 500mg”.

The following product of the M/s Don Valley, Lahore was approved subject to the dedicated section in 201 st meeting of

the me-too committee.

.

Propol Capsules.Each capsule contains:-Glucomannan………500mg.

5x10’s Rs. 357.50 Approved subject to the dedicated section for this product.

But the “Glucomannan” is a dietary fiber derived from the roots of the “Amorphophallus Konjac' and it is water soluble

polysaccharide. As it is dietary supplement therefore it may not be registered as a drug.

The firm also has the Registration of “Propol Sachet 1.5gm” Registration No. 018163.

Decision:- The board decided to issue show cause for “Propol Sachet 1.5gm” Registration No. 018163.

Case No.43.

M/s. Drugs Inn Pakistan Islamabad have requested for transfer of registration of from import to local toll

manufacturing by M/s. Biorex Pharmaceuticals, Kahuta Triangle Islamabad of following products:-

S. No. Name of the Drug(s) Reg. No. Abroad manufacturer.

Date of Registration

1. Prezone 250mg IM/IV InjectionsEach vial contains:-Ceftraixone Sodium eq. to 250 mg Ceftriaxone Sodium base.

022619 M/s. Dong Kwang

Pharmaceuticals Co.,

S. Korea

23-11-98

2. Prezone 500mg IM/IV InjectionsEach vial contains:-Ceftraixone Sodium eq. to 500 mg Ceftriaxone Sodium base.

023168 -do- 9-.3-99

3. Prezone 1gm IM/IV InjectionsEach vial contains:-Ceftraixone Sodium eq. to 1 gm Ceftriaxone Sodium base.

022654 -do- 4-12-98

4. Kefcef 250mg InjectionsEach vial contains:-Ceftraixone Sodium eq. to 250 mg Ceftriaxone Sodium base.

022694 M/s. Daewoo

Pharmaceuticals Ind.

C. , Ltd; Korea

30-01-99

brand name changed

from Cefpro to

Kefcef on 14-07-

1999

5. Kefcef 500mg InjectionsEach vial contains:-Ceftraixone Sodium eq. to 500

022695 -do-

S. No. Name of the Drug(s) Reg. No. Abroad manufacturer.

Date of Registration

mg Ceftriaxone Sodium base.

6. Kefcef 1gm InjectionsEach vial contains:-Ceftraixone Sodium eq. to 1 gm Ceftriaxone Sodium base.

022696 -do-

7. Gencef 1gm InjectionsCefotaxime Sodium eq. to 1gm Cefotaxime Sodium base.

022653 -do- 4-12-98

Decision:- The Board constituted a panel comprising of Mr. I. U. Beg, FID and ADC (I&E) to inspect M/s. Biorex

Pharmaceuticals, Islamabad.

Case No. 44.

Following products of M/s Friends Pharma Lahore were deferred for policy in 181 st-A committee meeting held

on 13th January, 2004.

S. No. Name of Manufacturer

Name of drug(s) with Composition

Pack size Demanded MRP

Remarks

1. M/s. Friends Pharma, Lahore.

Alprazolam Tablets 0.5mgEach tablet contains:-Alprazolam ………0.5mg(Anxiolytic Sedatives)

3x10’s Rs.171.00 Deferred for policy decision

2. -do- Stressnil 3mg Tablets Each tablet contains:-Bromazepam …..3mg(Anxiolytic Sedatives)

3x10’s Rs.109.00 -do-

Decision: - The registration board while considering inspection report of FID, Lahore dated 20-08-2007 in which FID has

found serious violations in QC Lab, and raw material stores of the firm decided to reject the applications.

Case No. 45.

Following products of M/s. Welwrd Pharmaceuticals Hattar were deferred in 194 th meeting of the Drugs

Registration Board for policy decision.

Name of the Drug Pack size

Welbip InjectionEach ml contains:-Buprenorphine (as Hcl) ..0.3mg(Narcotic Analgesic)

1ml x5’s

Nalbowel InjectionEach ml contains:-Nalbuphin HCl….10mg(Narcotic Analgesic)

5x1ml

Nalbowel InjectionEach ml contains:-Pentazocine (as lactate)….30mg(Narcotic Analgesic)

1ml x5’s

Tazil InjectionEach ml contains:-Pentazocine (as lactate)….30mg(Narcotic Analgesic)

1ml x5’s

Decision:- The board deferred the case for submission of Audited financial statement to verify the sales volume.

Evidence of tax paid on imports as per annex 10 of income tax return and inspection of the firm by a panel of inspectors.

Case No. 46

The Me-Too committee of the Registration Board deferred the following product of M/s. Orta

Laboratories Lahore in its 197th-A meeting held on 29th May, 2006. The firm has General tablet section with HVAC and

has submitted their production plan & cleaning validations.

Alprazota Tablets 0.50mg.Each Tablet Contains:-Alprazolam……………..0.50mg.

3x10’s -do- Deferred

Decision:- The request of the firm was rejected as the firm has no dedicated facility to manufacture the drugs.

Case No. 47

The Me-Too committee of the Registration Board deferred the following product of M/s. Pacific Laboratories

Lahore in its 197th-A meeting held on 29th May, 2006.

Name of Drug. Pack Size Demanded Decision.

Price.Estar Tablets. Each Tablet Contains:-Escitalopram………….10mg.

14’s Rs.683.10 Approved* subject to renewal of the

license of the firm.

C-Cure 40.Tablets.Each Tablet Contains:-Esomeprazole magnesium trihydrate…..........44.5mg

14’s Rs. 320.00 -do-

C-Cure Tablets 20mg.Each Tablet Contains:-Esomeprazole …………….20mg.

14’s Rs.170.00 -do-

CASE NO. 48. M/s. ACME Laboratories Pakistan (Pvt.) Ltd; Lahore have requested for extension in toll manufacturing

of following products:-

S. No, Name of the Drug(s) Reg. No.

1. Esopra Tablets 20mg

(Esomeprazole)

2. Esopra Tablets 40mg

(Esomeprazole)

3. Mokast Chewable Tablets 4mg

(Montelukast)


(Montelukast)


(Montelukast)

6. Gatox 400mg

(Gatifloxacin)

7. Azicin Suspension

(Azithromycin 200 mg/5ml)

8. Vanlex SR 37.5mg Capsule

(Venlafaxine)

9. Vanlex SR 75mg Capsule

(Venlafaxine)

They were granted the registration of above products for a period of two years from 31 st December 2004 to 31st

December 2006. The request for extension is not supported with application on Form-5 by the manufacturer and

prescribed fee.

Decision:- The request of the firm was rejected as the application is not on form 5 and not supported with fee. .

CASE NO. 49. M/s. Akhai Pharmaceuticals Karachi have requested for transfer of registration of their following

products from import to local toll manufacturing as under:-

S. No.

Name of Firm Name of Drug(s) Reg. No.

Date of registration


1. M/s. Akhai Pharmaceuticals

Karachi.

Succicholine 100mg Injections


Suxamethonium Shloride .................................. 100mg

015741 07-09-1994

Renewed on

05-08-04

M/s. Ipram Pharmaceuticals

Islamabad.

2. -do- M/s. Thiopen Injections


Thiopentone Sodium

................................... 500mg

015745 07-09-1994

Renewed on

05-08-04

-do-

3. -do- Ramezole Capsules

Each capsule contains:-

017423 13-07-1995

Renewed on

M/s. Cirin Pharmaceuticals Hattar.

S. No.

Name of Firm Name of Drug(s) Reg. No.

Date of registration


Omeprazole ................ 20mg 15-01-2005

They have therefore, requested to grant them the permission for transfer of registration from import to local toll manufacturing.

Decision: - The registration board deferred the case and decided to call the proposed manufacturers for personal hearing.

Case No.50.

M/s. Guyton Pharmaceuticals Lahore have informed that they were granted the registration of “Lidocaine 1% inj”

which will be provided as diluent with their powder injections “Fortexone 1gm”. They need “Lidocaine 1% 2ml” which

will be provided with “Fortexone Injections 250mg and 500mg” (for IM use only). Due to this the launch of this product

has been delayed. The have therefore, requested to issue the registration of “Lidocaine 1% 2ml” free of cost.

Decision;- The request of the firm was acceded to.

Case No.51.

The DDC (RRR) has forwarded a letter of M/s. Lahore Chemical & Works Pharmaceuticals Lahore wherein he

has informed that the firm has applied for renewal of registration of following products:-

S. No. Name of Drug(s) Reg. No.

1. Tracer Injections 250gm

(Cefotaxime)

028615

2. Tracer Injections 1gm

(Cefotaxime)

028616

During the scrutiny, it was observed that the above mentioned products that the above mentioned products had

been registered in the name of M/s. Ideal Pharmaceuticals Industries Lahore through toll manufacturing M/s. Lahore

Chemical & Pharmaceuticals Works Lahore.

It is submitted that the above product was registered on 16-08-2002 and has expired on 15-08-2007.




Case No.52.

M/s. Majeed Sons Rawalpindi have informed that they were granted the following product to import from M/s.

Chiron S.r.I. Italy:-

S. No. Name of Drug(s). Reg. No.

1. Morupar Lyophilized Injecable suspension + solvent.

Each 0.5ml dose contains:-

-1000 TCID /50 of measles virus

-1000 TCID/50 of Rubella virus

-5000 TCID /50 of mumps virus

013272

2. Morbilvax Injections

(Freeze Dried) Suspension of attenuated Schwars Strain of measles virus

Each 0.5ml dose contains:-

Not less than 1,000 TCID 50 of virus and a residue of not more than 50mcg each of neomycin B-sulfate and Kanamycin.

013528

They intend to import the naked vials of above mention products and locally labelling and repacking by their

sister concern M/s. Amson Vaccine & Pharma (Pvt.) Ltd; Islamabad. They have further informed that M/s. Amson

Vaccine & Pharma is already formulating vaccines for Tetanus and Hepatitis B and also carrying out the

labeling/repacking of naked vials of Rabies vaccines.

They have therefore, requested to permit for import of naked vials from M/s. Chiron S.r.I. Itay and locally

labeling and repacking by M/s. Amson Vaccines & Pharma (Pvt.) Ltd; Islamabad.

Decision: - The request of the firm was acceded to initially for 1 year and further extension shall be granted for 12 & ½

years subject to satisfactory progress report.

Case No.53.

The Drugs Registration Board in its 204th meeting held on 23rd - 24th February 2007 decided to defer the following

product of M/s Davis Pharma Islamabad for the submission of revised formulation by the firm as two anti histamine are

not required in one formulation and it has been discontinued in BNF-

Formulation applied initially Formulation requested by the firm (Deferred)

D-Cold Tablets

Each Tablet contains:

Paracetamol................................250 mg

Mepyramine Maleate.................6.5 mg

Pheniramine Maleate ................6.5 mg

Phenylpropanolamine Hcl..........13 mg

D-Cold Tablets

Each Tablet contains:-

Paracetamole............................250mg

Mepyramine Maleate.................6.5mg

Pheniramine maleate .................6.5mg

Pseudoephedrine HCl.................13mg

Now they have again requested for the registration of D-Cold Tablets with following revised formulation:-

D-Cold Tablets

Each tablet contains:-

Paracetamol .................... 250mg

Pheniramine Maleate ...... 6.5mg

Pseudoephedrine HCl ..... 15mg

Decision:- The request of the firm for the registration of revised formulation was approved*.

Case No.54

M/s. Martin Dow Pharmaceuticals (Pakistan) Limited Lahore have informed that they applied for registration of following

two products:-

Asmaterol Tablets 10mg


Bambuterol………10mg

(Anti-asthamatic)

10’s

3x10’s

Rs.40.00

Rs.1040.00

Approved




(Anti-asthamatic)

10’s

3x10’s

Rs.750.00

Rs.2160.00

Approved

The Drugs Registration Board in its 191st meeting approved the “Asmaterol Tablets 20mg” while due to

typographic mistake the same strength was approved as duplicate. The firm has provided the file and the copy of triplicate

challan.

They have therefore, requested to consider the application of following product.:-




(Anti-asthamatic)

Decision:- The request of the firm for the registration was approved*.

CASE NO. 55. Registration of Quinolones in capsule Dosage form.

It has been noted that Quinolones in Pakistan are registered not only in injectable, dry suspension & tablet dosage

forms but also in Capsule forms. In the developed countries like USA, Canada, Britain capsule dosage form is not

available. Many of the drug registrations in capsule form are approved in recent meetings but registration letters were not

issued.

The Floroquinolones are available in the following:-

Oral

Ciprofloxacin

Oral suspension (U.S)

Tablet (U.S & Canada)

Enoxacin

Tablet (U.S)

Gatifloxacin

Tablets (U.S)

Levofloxacin

Tablets (U.S. and Canada)

Lomefloxacin

Tablets (U.S)

Moxifloxacin

Tablets (U.S)

Norfloxacin


Ofloxacin


Sparfloxacin

Tablets (U.S)

Parenteral

Ciprofloxacin

Injection (U.S. and Canada)

Gatifloxacin

Injection (U.S)

Levofloxacin

Injection (U.S and Canada)

Ofloxacin

Injection (U.S)

Capsule Dosage forms available

in Pakistan.

Drug Brand Name

Levofloxacin Glit 250mg & 500mg

(S.J.& G Fazul Illahi)

Zevo 250 mg &

500mg (Llyod’s)

Ciprofloxacin Ciprin 250mg &

500mg (Werrick)

Ciprocam

250mg& 500mg

(Chas A. Mendoza)

Nelsoquin 205mg &

500mg (Llyod’s)

Enoxacin Enoxazan (zafa)

Gatifloxacin Nil

Lomefloxacin -do-

Moxifloxacin -do-

Norfloxacin -do-

Ofloxacin Capflo (Llyod’s)

Oflobiotic (Zafa)

Orvacin 200mg

(Bloom)

Sparfloxacin Nil

Decision:- The board decided to ask the manufacturers of the quinolones in capsule dosage form to provide any

established bioequivalence studies and advantage of capsules over tablets.

CASE NO. 56. The Drugs registration Board in its 206th meeting approved the following products of M/s Welmark

Pharmaceuticals Hattar:-

S.No Name of drug (s) & Composition Packing M R P Decision1. Miproxin. Infusion

Each 100ml contains:- Ciprofloxacin…………….200mg(B.P)

100ml Rs.120.00M/s.WelMApproved subject to the verification of approved Section (LVP or SVP).

2. SelFlox Infusion.Each 100ml contains:- Levofloxacin……………..500mg

100ml Rs.700.00 -do-

The Registration letter was not issued as the firm has no large volume parenteral section. It is submitted that

large volume parenterals are single unit doses >100 ml in volume. Typical solutions include water, dextrose

(5–50%), amino acids, salts and viscous Total Parenteral Nutrition (TPN) components with batch sizes in the

tens of thousands of liters.

Decision:- The request of the firm was acceded to.

CASE NO. 57. Following firms have requested for registration of following drugs for export purpose only:-

S. No. Name of the Firm. Name of Drugs

1. M/s. Libra (Private) Limited Peshawar.

ED-Gra TabletsEach tablet contains:-Sildenafil Citrate ........... 100mg

2. -do- ED-Gra TabletsEach tablet contains:-Sildenafil Citrate ........... 50mg


Case No.58

The following formulations are available in the market registered in the name of firms mentioned against each.

The case is submitted for the consideration of the Board whether these formulations are rational or irrational:-

Name of the firm.

Reg. No. Name of the Drug(s).

M/s. Abbot Laboratories (Pvt.) Ltd; Karachi.

006281 Rondec Syrup

Each 5ml contains:-

Dextromethorphan Hydrobromide U.S.P. .................... 10mg

Chlorpheniramine Maleate U.S.P. ................................ 2mg

Ephedrine Hydrochloride U.S.P. .................................. 5mg

Phenylepphrine Hydrochloride U.S.P. .......................... 5mg

Phenylephrine Hydrochloride U.S.P. ............................ 5mg

Ammonium Chloride U.S.P. ......................................... 40mg

Ipacac fluid extract U.S.P. ......................................... 0.005ml

-do- 007278 Cofcol Elixir

Each 5ml contains:-

Paracetamol U.S.P. ......................................................... 325mg

Pseudoephedrine HCl U.S.P. .......................................... 30mg

Chlorpheniramine Maleate .............................................. 1mg

Dectramethorphan Hbr ..................................................... 10mg

Vitamin C .......................................................................... 50mg

in a plaeasant tasting elixir

M/s. Novartis Pharma

Pakistan Ltd;

Jamshoro.

007449 Mosegor- Syrup

Each 10ml pleasantly flavoured syrup contians:-

Pizotifen (Novartis Specs) .......... 0.5mg (as hydrogen malate).

Thiamine hydrochloride .............................................. 1.75mg

Riboflavin Phosphate ................................................... 2.62mg

Pyridoxine hydrochloride ............................................. 1.54mg

Nicotinamide ............................................................... 10.50mg

-do- 006282 Mosegor Syrup

Each 5ml pleasantly mandarine flavoured syrup contains:-

Pizotifen (Novartis Specs.) ........................................... 0.25mg

M/s. Abbot Laboratories (Pvt.) Ltd; Karachi.

007279 Cofcol Tablets


Paracetamol ................................................................... 325mg

Phenylepphrine Hydrochloride ...................................... 30mg

Dectramethorphan Hbr ................................................... 10mg

Chlorpheniramine Maleate .............................................. 1mg

Vitamin C ......................................................................... 50mg

Decision:- The case was deferred for next meeting.

Case No.59. M/s. Surge Laboratories Lahore has applied for extension in the toll manufacturing permission of the under

mentioned drugs. Details are as below:-

S .No. Name of Products Reg: No. Toll Manufacturer

Date of initial

registration

First permission

for toll.1. Esprol 20mg Capsules

Each Capsules Contains:-Esomeprazole……20mg

041893 M/s. Nabiqasim Industries,Karachi

27-12-2005 to 30-06-

2006

Up to 31-12-2006

2. Esprol 40mg CapsulesEach Capsules Contains:-Esomeprazole……40mg

041894 -do- -do- -do-

3. Prexa 10mg CapsulesEach Capsules Contains:-Escitalopram……..10mg

041903 -do- 05-01-2006 to 30-06-

2006

-do-

4. Pentigab 100mg CapsulesEach Capsules Contains:-Gabapentin………100mg

041906 -do- -do- -do-

5 Pentigab 300mg CapsulesEach Capsules Contains:-Gabapentin………300mg

041907 -do- -do- -do-

6. Pentigab 400mg CapsulesEach Capsules Contains:-Gabapentin………400mg

041908 -do- -do- -do-

The permission has expiring on 31-12-2006. Now the firm has again requested for last time extension in

contract manufacturing permission of the aforesaid products till 31-12-2007. They have deposited the fee of Rs.8000/-

each for this purpose.

Decision:- The request of the firm was acceded to.

Registration of drugs.

S. No Name of Manufacturer

Brand name/ Label claim Proposed Pack size

Proposed Price

Remarks

1. M/s. Popular Chemical Works,

Lahore.

Dekof Syrup.Each 5ml Contains:-Triprolidine HCl……………..2mg.Pseudoephedrine HCl……….30mg.Codeine Phosphate…………..10mg.

60ml Rs.52.00 Approved*/ Installation and verification of

HVAC system in the section.

2. - -do- Dekof Plus Syrup.Each 5ml Contains:-Triprolidine HCl……………..2mg.Pseudoephedrine HCl……….30mg.Codeine Phosphate…………..10mg.Guaifenesin………………….100mg.

60ml Rs.55.00 Rejected as the firm did not apply on form 5-D & the

firm did not mention the

reference of already registered product/..

3. M/s. Hamaz Pharmaceuticals,

Multan.

Wormazine Syrup.Each 5ml Contains:-Piperazine Citrate eq. to Piperazine Hydrate…………..75mg.

30ml Rs. 15.00 Approved*

4. M/s. Renacon Pharma,Lahore.

Renacarb Concentrate (RBG-35)Contains :-Sodium...........................138.0 mmol/lPotassium........................2.0 mmol/lCalcium..........................1.25 mmol/lMagnesium…………….0.75 mmol/lAcetate…………………5.0 mmol/lChloride……………….107.0 mmol/lBicarbonate....................35.0 mmol/lGlucose...........................5.5 mmol/l

4 Litre5 Litre

Rs. 400.00Rs. 490.00

Rejected as the renewal of the firm

is pending on its part.

5. -do- Renacarb Concentrate (RBG-36)Contains :-Sodium...........................138.0 mmol/lPotassium........................2.0 mmol/lCalcium..........................1.25 mmol/lMagnesium…………….0.75 mmol/lAcetate…………………5.0 mmol/lChloride……………….106.0 mmol/lBicarbonate....................36.0 mmol/lGlucose...........................5.5 mmol/l

4 Litre5 Litre

Rs. 400.00Rs. 490.00

-do-

6. M/s. Raazee Therapeutics,

Kasur.

Xomal Plus DS Suspension.Each 5ml Contains :-Artimether......................30mg.Lumefantrine…………...180mg.

60ml Not mentioned.

Rejected as the strength has not

been recommended by the WHO.

7. -do- Xomal Plus Suspension.Each 5ml Contains :-Artemether......................15mg.Lumefantrine…………...90mg.

60ml Not mentioned.

-do-

8. -do- Xomal Plus Tablets.Each Tablet Contains:-Artemether………………….40mg.Lumefantrine……………….240mg.

8’s -do- -do-

9. -do- Xomal-A Tablets.Each Tablet contains:-Artesunate……………….50mg.Amodiaquine HCl………..153mg.

1x3’s -do- Approved*

10. -do- Xomal SP Fort Tablets.Each Tablet Contains:-Artsunate…………………100mg.Sulphadoxine……………..500mg.Pyrimethamine…………….25mg.

9’s -do- -do-

11. -do- Xomal SP Tablets.Each Tablet Contains:-Artsunate………………..50mg.Sulphadoxine……………500mg.Pyrimethamine………….25mg.

9’s -do- -do-

12. -do- Xomal Tablets.Each Tablet Contains:-Artemether……………………20mg.Lumefantrine…………………120mg.

16’s -do- -do-

13. M/s. Ameer Pharma,Lahore.

Sodalyzer Syrup.Each 5ml Contains:-Sodium Acid Citrate…………1.25mg.

120ml450ml

Rs. 18.00Rs. 30.00

Approved*

14. -do- Amedone Suspension.Each 5ml Contains:-Domperidone………………...5mg.

60ml120ml450ml

Rs. 27.49Rs. 70.33Rs. 140.00

-do-

15. -do- Clomin Syrup.Each 5ml Contains:-Metoclopramide HCl B.P………5mg.

50ml Rs. 17.60 -do-

16. -do- Amegran Suspension.Each 5ml Contains:-Nalidixic Acid………………250mg.

60ml Rs. 33.71 -do-

17. -do- Amozine Syrup.Each 5ml Contains:-Cyclizine Hcl………………12.5mg.

60ml Rs. 14.90 -do-

18. -do- Chikymol 6 Plus Suspension.Each 5ml Contains:-Paracetamol………………..250mg.

60ml450ml

Not mention.

-do-

19. -do- Musalac Syrup.Each 5ml Contains:-Lactulose………………….10gm.

120ml240ml

Rs. 148.63Rs. 280.63

-do-

20. -do- Roshizine Syrup.Each 5ml Contains:-Cetirizine 2HCl…………….5mg.

60ml Rs. 29.78 -do-

21. -do- Clomin Drops.Each ml Contains:-Metoclopramide HCl……….1mg.

20ml Rs.10.00 -do-

22. -do- Chikymol (Paediatric Drops)Each ml Contains:-Paracetamol………………..12mg.

15ml Rs. 15.40 -do-

23. -do- Adrenaline Injection.Each ml Contains:-Adrenaline (as acid tartrate)…..1mg.

1mlx100 Amp.

Rs. 158.75 -do-

24. -do- Tramic Injection.Each 5ml Contains:-Tranexamic Acid BP…………250mg.

5mlx10Amp

Rs. 303.00 -do-

25. -do- Y-Dex Injection.Each ml Contains:-Lignocaine HCl B.P………..2% w/v

2mlx100 Amp.

10mlx50 Amp.

Rs. 178.00

Rs. 611.60

-do-

26. -do- Y-Dex Injection.Each ml Contains:-Lignocaine HCl...................2% w/vAdrenaline........................0.001%

2mlx100 Amp.

10mlx50 Amp.

Rs. 225.00

Rs. 631.16

-do-

27. -do- Jekazine Injection.Each ml Contains :-Promethazine HCl B.P………..25mg.

1mlx100 Amp.

Not mention.

-do-

28. -do- Amozine Injection.Each ml Contains:-Cyclizine (as Lactate) USP……50mg.

1mlx20 Amp.

Rs. 116.79 -do-

29. -do- M-Flox Injection.Each 100ml Contains:-Ofloxacin as HCl B.P………..200mg.

100ml Vial.

Rs. 140.00 -do-

30. -do- C-Flox Injection.Each 100ml Contains:-Ciprofloxacin Lactate B.P eq. To Ciprofloxacin..…………….200mg.

100ml vial. --- -do-

31. -do- Clomin Injection.Each 2ml Contains:-Metoclopramide HCl…………10mg.

2mlx10 Amp.

2mlx100 Amp.

Not mention.

-do-

32. -do- Ame-Flox Injection.Each 100ml Contains:-Levofloxacin (as Hemihydrate) BP………...500mg.

100ml vial Not mention.

-do-

33. M/s. CCL, Pharmaceuticals,

Lahore.

Sucrofer-T Tablets.Each Tablet Contains:-Iron Protein Succinylate eq. To Elemental Iron…………………20mg.

14’s As per Brand

Leader.


is pending on its part and the the

firm did not apply on form 5-D.

34. -do- Sucrofer-F Tablets.Each Tablet Contains :-Iron protein succinylate eq. To Elemental Iron...................20mg.Folic Acid..........................2.5mg.

14’s -do- -do-

35. -do- Deflam Tablets.Each Tablet Contains:-Diclofenac Potassium B.P……75mg.

20’s Rs. 10.00/ Tablet.



36. M/s. Shaigan Pharmaceuticals,

Rawalpindi.

Omper Injection.Each Vial Contains:-Omeprazole Sodium…………40mg.

1’s As per SRO.

Rejected as the firm has no

approved area for lyophilized products.

37. -do- Famot-40 Injection.Each Vial Contains:-Famotidine…………………40mg.

1’s -do- -do-/ The firm did not apply on form-

5-D38. -do- Famot-20 Injection.

Each vial contains:-Famotidine…………………20mg.

1’s -do- -do-

39. -do- Lyozol Injection.Each Vial Contains:-Rabeprazole Sodium……….20mg.

1’s -do- Rejected as the firm has no

approved area for lyophilized products.

40. -do- Prezal-15 Injection.Each Vial Contains:-Lansoprazole Sodium………15mg.

1’s -do- -do-

41. -do- Prezal-30 Injection.Each Vial Contains:-Lansoprazole Sodium………30mg.

1’s -do- -do-

42. M/s. Zesion Pharmaceuticals,

Islamabad.

Nelsoquin Capsules.Each Capsule Contains:-Ciprofloxacin (as HCl).............250mg.

1x10’s Rs. 200.00 Rejected as the firm has already

got the Registration of the same drug/

strength and dosage form.

43. -do- Zevo Capsules.Each Capsule Contains :-Levofloxacin (as Hemihydrate)..................500mg.

1x10’s Rs. 500.00 -do-

44. -do- Esompra Capsules.Each Capsule Contains :-Esomeprazole (as Magnesium Trihydrate).......40mg.

14’s Rs. 320.00 -do-

45. -do- Nelsoquin Tablets.Each Tablet Contains :-Ciprofloxacin as HCl.............500mg.

1x10’s Rs. 350.00 -do-

46. M/s. Amson Vaccine & Pharma.Islamabad.

Artemef Tablets.Each Tablet Contains :-Artesunate........................200mg.Mefloquine HCl................250mg.



Lidoject 2% Injection.Each 10ml Ampoule Contains :-Lignocaine HCl USP............200mg.

10’s Rs. 160.00 Approved subject to the renewal of

the firm.

48. M/s. Dyson Research Laboratories,

Lahore.

Sulp Tablets 25mg.Each Tablet Contains:-Levosulpiride…………….25mg.

20’s Rs.180.00 Approved*

49. -do- Sulp Tablets 50mg.Each Tablet Contains:-Levosulpiride…………….50mg.

20’s Rs. 360.00 -do-

50. -do- Sulp Tablets 100mg.Each Tablet Contains:-Levosulpiride…………….100mg.

20’s Rs. 720.00 -do-

51. -do- Flexy Tablets 10mg.Each Tablet Contains:-Cyclobenzaprine HCl………..10mg.

20’s Rs. 300.00 Deferred for expert opinion/

submission of stability studies and

validation of method of

manufacturing.52. M/s. Aneeb

Pharmaceuticals,Lahore.

Cital-20 Tablets.Each Tablet Contains:-Citalopram (as Hydrobromide)…………20mg


53. -do- Dionac-S Tablets.Each Tablet Contains:-Diclofenac Sodium………….75mg.

2x10’s Rs.100.00 Approved*/ comparison of

dissolution profile with the originator.

54. -do- Fexdin Tablets.Each Tablet Contains:-Fexofenadine HCl……………120mg.


55. -do- Feropal Tablets.Each Tablet Contains:-Iron (as Iron III Hydroxide Polymaltose)………………..100mg.Folic Acid…………………..0.35mg.

1x10’s Rs. 65.00 -do-

56. -do- Esoneb-40 Capsules.Each Capsule Contains:-Esomeprazole (as Magnesium Trihydrate)………………….40mg.

2x10’s Rs. 200.00 -do-

57. M/s. Nova Pharmaceuticals,

Peshawar.

Orinse Mouth Wash.Each 5ml Contains:-Chlorhexidine Gluconate……..0.2%Benzydamine HCl……………..15%


58. -do- Fomax Tablets.Each Tablet Contains:-Alendronate Sodium USP……10mg.

10’s Rs. 270.00 -do-

59. -do- Fomax Tablets.Each Tablet Contains:-Alendronate Sodium USP….70mg.

4’s Rs. 400.00 -do-

60. -do- Welpol Oral Liquid.Each 5ml Contains:-Paracetamol BP…………….160mg.

60ml Rs. 18.00 -do-

61. M/s. Envoy Pharmaceuticals,

Lahore.

Co-Art Tablets 20mg.Each Tablet Contains :-Artemether………………..20mg.Lumefantrine……………..120mg.

2x8’s As per SRO

Approved*

62. -do- Co-Art Tablets 40mg.Each Tablet Contains :-Artemether………………..40mg.Lumefantrine……………..240mg.

1x8’s As per SRO

Rejected as the combination in the mentioned strength

is not WHO approved.

63. -do- Tenorex Tablets.Each Tablet Contains:-Tizanidine HCl…………….2mg.

1x10’s As per SRO

Approved*

64. M/s. Mass Pharmaceuticals,

Lahore.

Veno Injection.Each 5ml Ampoule Contains:-Iron (as Sucrose)……………..100mg.

5ml Rs. 240.00 -do-

65. M/s. Spectra Pharmaceuticals,

Hattar.

Fazolin 1gm Injection.Each Injection Contains:-Cefazolin Sodium eq. to Cefazolin………………….1gm.

Not mention.

As fixed by Govt.

-do-

66. -do- Fazolin 500 Injection.Each Injection Contains:-Cefazolin Sodium eq. to Cefazolin………………….500mg.

Not mention.

As fixed by Govt.

-do-

67. -do- Ropezon 1gm Injection.Each Injection Contains:-Cefoperazone sodium eq. to cofoperazone ………………1gm.

-do- -do- -do-

68. -do- Ropezon 250mg Injection.Each Injection Contains:-Cefoperazone sodium eq. to cofoperazone ………………250mg.

-do- -do- -do-

69. -do- Ropezon 500mg Injection.Each Injection Contains:-Cefoperazone sodium eq. to cofoperazone ………………500mg.

-do- -do- -do-

70. -do- Omnicef 1gm Injection.Each Injection Contains:-Cephradine with L-arginine eq. to Cephradine……………….1gm.

-do- -do- -do-

71. -do- Omnicef 250mg Injection.Each Injection Contains:-Cephradine with L-arginine eq. to Cephradine……………….250mg.

-do- -do- -do-

72. -do- Omnicef 500mg Injection.Each Injection Contains:-Cephradine with L-arginine eq. to Cephradine……………….500mg.

-do- -do- -do-

73. -do- Curocef 250mg Injection.Each Injection Contains:-Cefuroxime sodium eq. to Cefuroxime……………..250mg.

-do- -do- -do-


-do- -do- -do-


-do- -do- -do-

76. -do- Sytax 500mg Injection.Each Injection Contains:-Cefotaxime sodium eq. to Cefotaxime……………….500mg.

-do- -do- -do-

77. -do- Setrazone 500mg Injection.Each Injection Contains:-Ceftriaxone sodium eq. to Ceftriaxone………………..500mg.

-do- -do- -do-

78. -do- Syzid 500mg Injection.Each Injection Contains:-Ceftazidime…………………500mg.

-do- -do- -do-

79. -do- Rofixime Suspension 100mg.Each 5ml Contains:-Cefixime………………….100mg

60ml -do- -do-

80. -do- Rofixime DS Suspension 200mg. Each 5ml Contains:-Cefixime………………….200mg.

60ml -do- -do-

81. -do- Bactinir Suspension 125mg.Each 5ml Contains:-Cefdinir…………………125mg.

60ml -do- -do-

82. -do- Bactinir Suspension 250mg.Each 5ml Contains:-Cefdinir…………………250mg.

60ml -do- -do-


Genxat Injection.Each 2ml Ampoule Contains:-Gentamicin Sulphate USP eq. to Gentamicin Base…………….80mg.

2’s Rs. 50.00 Approved subject to the renewal of

the firm.

84. M/s Bio-Labs,Rawalpindi.

Pantab Tablets.Each Tablet Contains:-Pantoprazole (as Sodium Sesquihydrate)……..40mg


85. M/s. Global Pharmaceuticals,

Islamabad.

Sedodine XR Tablets.Each Tablet Contains:-Desloratadine………………..5mg.Pseuddoephedrine………..240mg.

5’s Rs. 630.00 Rejected as the firm quoted the

wrong reference of the me-too product/

Not applied on Form-5D.

86. M/s. Pharmedic Laboratories,

Lahore.

Tamsul SR Capsules.Each Capsule Contains:-Tamsulosin HCl……………400mcg.

3x10’s Rs. 198.00 Deferred as the product is already in expert opinion.

87. M/s. Ferozsons Laboratories,Nowshera.

Mantra Tablets.Each Tablet Contains:-Memantine HCl………….10mg.

3x10’s Not mention.

Approved*

88. M/s. Dyson Research Laboratories,

Lahore.

Gaspride Tablets.Each Tablet Contains:-Itopride Hydrochloride……..50mg.

10’s Rs. 200.00 -do-

89. M/s. Medizan Laboratories,Islamabad.

Lumeart Tablets.Each Tablet Contains:-Lumefantrine……………….20mg.Artemether…………………120mg.

2x8’s Rs. 34.00 -do-.

90. M/s. Amson Vaccine & Pharma,Islamabad.

Amvir 250mg injection.Each vial contains:-Acyclovir Sodium……………250mg.

1’s Rs. 450.00 -do-

91. -do- Amvir 500mg injection.Each vial contains:-Acyclovir Sodium……………500mg.

1’s Rs. 850.00 -do-

92. M/s. Schazoo Labs;Lahore.

Gemacin Tablets.Each Tablet Contains:-Gemifloxacin as Mesylate……320mg.


-do-

93. -do- Artemex-L DS Tablets.Each Tablet Contains:-Artemether…………………40mg.Lumefantrine………………240mg.

1x8’s Rs. 37.5/ Tablet

Rejected as the combination in the said strength is not WHO approved.

94. M/s. Panacea Pharmaceuticals,

Rawat.

Itracon Capsules.Each Capsule Contains:-Itraconazole...........................100mg.


95. M/s. Vision Pharmaceuticals,

Islamabad.

Hydrocortef Injection.Each Vial Contains :-Hydrocortisone Sodium eq. toHydrocortisone USP………….100mg.

1’s As fixed by Govt.

Rejected as the firm has no section.

96. -do- Hydrocortef Injection.Each Vial Contains :-Hydrocortisone Sodium eq. toHydrocortisone USP………….250mg.


-do-

97. M/s. PDH, Pharmaceuticals,

Lahore.

Calcium-P Plus Suspension.Each 5ml Contains:-Elemental Calcium…………150mg.Vitamin B (Ergocalciferol)….400 i.u

120ml Rs. 51.00 Rejected as the firm did not apply

on Form 5-D.

98. -do- Coughllin Syrup.Each 5ml Contains:-Aminophylline……………….32mg.Diphenhydramine HCl……….8mg.Ammonium Chloride...............30mg.Menthol...................................0.98mg


99. -do- Dextromethorphan Cough Syrup.Each 5ml Contains:-Dextromethorphan HBr……13.5mg.

60ml Rs. 15.00 -do-


Kasur.

Ezumac Capsules 20mg.Each Capsule Contains:-Esomeprazole………………..20mg.


101. -do- Ezumac Capsules 40mg.Each Capsule Contains:-Esomeprazole………………..40mg.

14’s Rs. 323.00 -do-

102. -do- Lvecid Capsules 30mg.Each Capsule Contains:-Lansoprazole USP……………..30mg.

10’s 30% less than Brand

Leader.

-do-

103. -do- Montekarl Tablets 4mg.Each Tablet Contains:-Montelukast (as Sodium Salt)…4mg.


Leader.

-do-

104. -do- Montekarl Tablets 10mg.Each Tablet Contains:-Montelukast (as Sodium Salt)…10mg.

14’s -do- -do-

105. -do- Plavis Tablets.Each Tablet Contains:-Phloroglucinol HCl………….80mg.Trimethyl Phloroglucinol……80mg.

30’ -do- Rejected as same strength/combination has already been

rejected.

106. -do- Deslorat Tablets 5mg.Each Tablet Contains;-Desloratadine……………….5mg.


107. -do- Alfadol Tablets.Each Tablet Contains:-Alfacalcidol…………………0.5mcg.


Leader.

Approved*/ submission of

content uniformity testing.

108. -do- Fexotab Tablets 120mg.Each Tablet Contains:-Fexofenadine………………120mg.

10’ -do- Approved*

109. M/s. Mega Pharmaceuticals,

Lahore.

Movid Tablets 10mg.Each Tablet Contains:-Leflunomide………………..10mg.

30’s As per SRO

Approved*

110. -do- Movid Tablets 20mg.Each Tablet Contains:-Leflunomide………………..20mg.

30’s As per SRO

-do-

111. -do- Flurbi Tablet 50mg.Each Tablet Contains:-Flurbiprofen………………….50mg.

3x10’s As per SRO

-do-

112. -do- Flurbi Tablet 100mg.Each Tablet Contains:-Flurbiprofen………………….100mg.

3x10’s As per SRO

-do-

113. -do- Montel Talets 5mg.Each Tablet Contains:-Montelukast Sodium…………5mg.

14’s As per SRO

-do-

114. -do- Montel Tablets 10mg.Each Tablet Contains:-Montelukast Sodium…………10mg.

14’s As per SRO

-do-

115. -do- Tizan Tablets 2mg.Each Tablet Contains:-Tizanidine as HCl……………..2mg.

10’s As per SRO

-do-

116. -do- Tizan Tablets 4mg.Each Tablet Contains:-Tizanidine as HCl……………..4mg.

10’s As per SRO

-do-

117. -do- Rabex Tablets 10mg.Each Tablet Contains:-Rabeprazole Sodium………..10mg.

10’s As per SRO.

-do-

118. -do- Rabex Tablets 20mg.Each Tablet Contains:-Rabeprazole Sodium………..20mg.

10’s As per SRO.

-do-

119. -do- Agout Tablets 100mg.Each Tablet Contains:-Allopurinol…………………100mg.

5x10’s As per SRO

-do-

120. -do- Agout Tablets 300mg.Each Tablet Contains:-Allopurinol…………………300mg.

5x10’s As per SRO

-do-

121. -do- Synergy Tablets.Each Tablet Contains:-Metformin HCl……………..250mg.Glibenclamide………………1.25mg.

30’s As per SRO

-do-

122. -do- Synergy Tablets.Each Tablet Contains:-Metformin HCl……………..500mg.Glibenclamide………………2.5mg.

30’s As per SRO

-do-

123. -do- Synergy Tablets.Each Tablet Contains:-Metformin HCl……………..500mg.Glibenclamide………………5mg.

30’s As per SRO

-do-

124. -do- Coxib Tablets 100mg.Each Tablet Contains:-Celecoxib………………….100mg

2x10’s As per SRO

Rejected due to potential hazards.

125. -do- Coxib Tablets 200mg.Each Tablet Contains:-Celecoxib………………….200mg

2x10’s As per SRO

-do-

126. -do- Trufen Tablets 100mg.Each Tablet Contains:-Ketoprofen…………………100mg

3x10’s As per SRO

Approved*/ comparison of

dissolution profile with originator.

127. -do- Trufen Tablets 200mg.Each Tablet Contains:-Ketoprofen…………………200mg

3x10’s As per SRO

-do-

128. -do- Sparcin Tablets 100mg.Each Tablet Contains:-Sparfloxacin………………..100mg.

1x10’s As per SRO

Approved*

129. -do- Spasban Tablets 135mg.Each Tablet Contains:-Mebeverine HCl…………….135mg.

30’s As per SRO

-do-

130. -do- Megamin Tablets 500mcg.Each Tablet contains:-Mecobalamine……………….500mcg

10x10’s As per SRO

-do-

131. -do- Pentium Tablets.Each Tablet Contains:-Pantoprazole Sodium sesquihydrate eq. to Pantoprazole…………40mg.

10’s As per SRO

-do-

132. -do- Bonmax Tablets.Each Tablet Contains:-Alendronate Sodium………..10mg.

10’s As per SRO

-do-

133. -do- Epeson Tablets.Each Tablet Contains:-Eperisone HCl………………50mg.

100’s As per SRO

-do-

134. -do- Levocit Tablets.Each Tablet Contains:-Levocetirizine 2HCl…………5mg.

10’s As per SRO

-do-

135. -do- Cefac Capsules 250mg.Each Capsule Contains:-Cefaclor…………………..250mg.

12’s As per SRO

-do-

136. -do- Cefac Capsules 500mg.Each Capsule Contains:-Cefaclor…………………..500mg.

12’s As per SRO

-do-

137. -do- Cefzee Capsules 250mg.Each capsule Contains:-Cephalexin Monohydrate…...250mg.

12’s As per SRO

-do-

138. -do- Cefzee Capsules 500mg.Each capsule Contains:-Cephalexin Monohydrate…...500mg.

12’s As per SRO

-do-

139. -do- Curicef Capsules 500mg.Each Capsule Contains:-Cefadroxil…………………500mg.

12’s As per SRO

-do-

140. -do- Arte Capsules 40mg.Each Capsule Contains:-Artemether……………….40mg

10’s As per SRO

Rejected as the single ingredient

therapy of the antimalarial is not

required/ firm does not have the

general capsule section.

141. -do- Doxim Suspension.Each 5ml Contains:-Cefpodoxime……………..40mg.

50ml As per SRO

Approved*

142. -do- Megaroxime Suspension.Each 5ml Contains:-Cefuroxime as Axetil………..125mg.

50ml As per SRO

-do-

143. -do- Curicef Suspension 125mg.Each 5ml Contains:-Cefadroxil………………….125mg.

60ml As per SRO

-do-

144. -do- Curicef Suspension 250mg.Each 5ml Contains:-Cefadroxil………………….250mg.

60ml As per SRO

-do-

145. -do- Cefzee Suspension 125mg.Each 5ml Contains:-Cephalexin as Monohydrate…..125mg

60ml As per SRO

-do-

146. -do- Cefzee Suspension 250mg.Each 5ml Contains:-Cephalexin as Monohydrate…..250mg

60ml As per SRO

-do-

147. -do- Cefac Suspension 125mg.Each 5ml Contains:-Cefaclor………………….125mg.

60ml As per SRO

-do-

148. -do- Cefac Suspension 250mg.Each 5ml Contains:-Cefaclor………………….250mg.

60ml As per SRO

-do-

149. M/s. Pacific Pharmaceuticals,

Lahore.

Optimum Tablets.Each Tablet Contains:-Vitamin A (as Acetate and Beta Carotene)…………….5000 iu.Vitamin E (as dl-Alpha Tocopheryl Acetate………………….30 iu.Vitamin C (as ascorbic Acid)...60mg.Folic Acid…………………400mcg.Vitamin B1 (as Thiamine Mononitrate)……………..1.5mgVitamin B2 (as Riboflavin)…..1.7mg.Niacinamde…………………20mg.Vitamin B6 (as Pyridoxine hydrochloride)……………….2mg.Vitamin B12 (as Cyanocobalamin)…………….6mcg.Vitamin D………………..400 iu.Biotin………………………30mcg.

30’s Rs. 100.00 Deferred for policy.

Pantothenic Acid (as Calcium Pantothenate)………………..10mg.Calcium (as dibasic Calcium Phosphate)………………….162mg.Phosphorus (as Dibasic Calcium Phosphate……………….125mg.Iodine (Potassium Iodide)…150mcgIron (as Ferrous Fumarate)….18mcg.Magnesium (as Magnesium Oxide)………100mg.Copper (as Cupric Oxide)….2mg.Zinc (as Zinc Oxide)………15mg.Manganese (as Manganese Sulfate)……………………..2.5mg.Potassium (as Potassium Chloride)……………………40mg.Chloride (as Potassium Chloride)……………………36.3mg.Chromium (as Chromium Chloride)……………………25mcg.Molybdenum (as Sodium Molybdate)…………………25mcg.Selenium (as Sodium Selenate)……………………25mcg.Vitamin K1 (as Phytonadione)………………25mcg.Nickel (as Nickelolus Sulfate)………………………5mcg.Tin (as Stannous Chloride)….10mcgSilicon 9as Sodium Metasilicate)………………..10mcg.Vanadium (as Sodium Metavanadate)………………10mcg.

150. -do- Supravit Tablets.Each Tablet Contains:-Vitamin A (3333ui) (retinol)….3333iuVitamin B1 (thiamine)……….20mg.Vitamin B2 (riboflavin)……..510mg.Vitamin B6 (Pyridoxine)……..10mg.Vitamin B12 (cynocobalamin)…5mcgVitamin C (ascorbic acid)........150mgVitamin D3 (200iu) (Cholecalciferol)......................500iuVitamin E (d-a-tocopherol)……10mgBiotin (Vitamin H)……………25mgPantothenic acid…………..11.6mg.Folic acid…………………..1mg.Niacinamide………………..50mg.Calcium-D-pantothenate……11.6mg.Magnesium (Glycerophosphate, sulphate)…………………….18.1mg.Iron (Sulphate)………………50mg.Manganese (Sulphate)……….0.5mg

20’s30’s

Rs. 80.00Rs. 100.00

-do-

Phosphorus (Glycerophosphate)…………25.5mg.Copper………………………1mg.Zinc (Sulphate)……………0.5mg.Molybdenum (Rocher)……..0.1mg.


Lahore.

Cefoprim-500 Injection.Each vial contains:-Cefepime as Hcl……………..500mg.

1’s 5% than brand leader

Approved*

152. -do- Cefoprim-1000 Injection.Each vial contains:-Cefepime as Hcl…………….1000mg.

1’s 5% than brand leader

-do-


Islamabad.

Malozef Tablets.Each Tablet Contains:-Artemether………………….20mg.Lumefantrine……………….120mg.


154. -do- Exolide DS 125mg.Each 5ml Contains:-Clarithromycin…………….125mg.

60ml Rs. 250.00 -do-

155. -do- Zithrocaps DS 200mg.Each 5ml Contains:-Azithromycin……………….200mg.

15ml Rs. 200.00 -do-

156. -do- Erybro Dry Suspension.Each 5ml Contains:-Erythromycin Ethylsuccinate eq. to Erythromycin……………200mg.Bromohexine HCl………..4mg.

60ml Rs. 45.00 -do-


Islamabad.

Levoride 25mg Tablets.Each Tablet Contains:-Levosulpiride………………25mg.

20’s Rs. 202.2 -do-

158. -do- Levoride 50mg Tablets.Each Tablet Contains:-Levosulpiride………………50mg.

20’s Rs. 202.2 -do-

159. -do- Orexin Tablets 20mg.Each Tablet Contains:-Piroxicam as B-Cyclodextrin……20mg.

10’s Rs. 150.32 -do-

160. -do- Gaba-P Capsules.100mg.Each Capsule Contains:-Gabapentin…………………100mg.

10’s Rs. 90.00 -do-


10’s Rs. 190.00 -do-


10’s Rs. 240.00 -do-

163. -do- Glucopan Capsules 500mg.Each Capsule Contains:-Glucosamine Sulphate……….500mg.

10’s Rs. 245.67 -do-

164. -do- Lincin Capsules 500mg.Each Capsule Contains:-Lincomycin HCl…………..500mg.

12’s Rs. 105.00 -do-

165. -do- Alafadol Capsules.Each Capsule Contains:-Alfacalcidol ………………..0.5ug.

10’s Rs. 170.46 Approved*/ submission of

content uniformity.

166. M/s. Mass Pharma (Pvt) Ltd;Lahore.

Aerol A Cream.Each Tube Contains:-Adapalene BP…………….0.1% w/w

15gm Rs. 500.00 Approved*

167. -do- De-Scab Lotion.Each Bottle Contains:-Permethrin…………………5% w/w

60ml Rs. 80.00 -do-

168. M/s. Cirin Pharmaceuticals,

Hattar.

Plasmocide Plus Suspension.Each 5ml Contains:-Artemether……………….15mg.Lumefantrine……………..90mg.

60ml Rs. 220.00 Rejected as the said strength/dosage

form is not WHO approved.

169. -do- Virex Tablets 200mg.Each Tablet Contains:-Ribavirin U.S.P…………….200mg.


170. -do- Virex Tablets 400mg.Each Tablet Contains:-Ribavirin U.S.P…………….400mg.

10’s Rs. 330.00 -do-

171. -do- Falsikil Tablets.Each Co-blister Tablet Contains:-Artesunate…………………50mg.And Mefloquine………………..250mg.

12+6’s Rs. 1400.00

Rejected as the combination in said

strength is not WHO approved.

172. -do- Tridar Tablets.Each Co-blister Tablet Contains:-Artesunate………………….50mg.And Sulfadoxine ………………..500mgPyrimethamine……………..25mg.

12+3’s Rs. 250.00 Approved*

173. -do- Examal-Plus Tablets.Each Co- blister Tablet Contains:-Artesunate………………….50mg.And Amodiaquine……………….153mg.

12+12’s Rs. 350.00 -do-

M/s. Shaigan Pharmaceuticals,

Rawalpindi.

Omper Plus-40 Capsules.Each Capsule Contains:-Omeprazole..........................40mg.Sodium Bicarbonate...........1100mg.

14’s As per SRO

Deferred as the Drug is already in the expert opinion.

174. -do- Omper Plus-20 Capsules.Each Capsule Contains:-Omeprazole........................20mg.Sodium Bicarbonate............1100mg.

14’s -do- -do-

175. -do- Maxflo Capsules.Each Capsule Contains :-Tamsulosin HCl.....................0.4mg.

2x10’s -do- Rejected as the firm did not apply

on Form 5–D.

176. -do- Fifex-D Tablets.Each Tablet Contains :-Fexofenadine HCl…………180mgs.Pseudoephedrine HCl…….240mgs.

10’s -do- Approved*/ installation and verification of

HVAC system in the section/

comparison of the dissolution profile with the originator.

177. M/s. Highnoon Laboratories,

Lahore.

Prelin Capsules 50mg.Each Capsule Contains:-Pregabalin………………….50mg.

10’s Rs. 408.00 Approved*/ subject to renewal of the

license of the firm

178. -do- Prelin Capsules 75mg.Each Capsule Contains:-Pregabalin………………….75mg.

10’s Rs. 598.00 -do-


10’s Rs. 789.00 -do-


10’s Rs. 1169.00

-do-


10’s Rs. 1979.00

-do-

182. -do- Rimona Tablets.Each Tablet Contains:-Rimonabant……………….20mg.

10’s Rs. 850.00 Deferred for expert opinion.

183. M/s. Webros Pharmaceuticals,

Islamabad.

Glutan Tablets 50mg.Each Tablet Contains :-Losartan Potassium...............50mg.


184. -do- Deltaflam Tablets 75mg.Each Tablet Contains :-Diclofenac Potassium.............75mg.

2x10’s Rs. 120.00 -do-

185. -do- Welfast Tablets 120mg.Each Tablet Contains :-Fexofenadine.........................120mg.

1x10’s Rs. 150.00 -do-

186. -do- Cuore Tablets 25mg.Each Tablet Contains :-Carvedilol............................25mg.

1x10’s Rs. 70.00 -do-

187. M/s. Vega Pharmaceuticals,

Lahore.

Floxcin Ear Drops.Each ml Contains :-Ofloxacin………………….3mg.


188. -do- Floxcin Ear Drops.Each ml Contains:-Ofloxacin………………..6mg.

5ml Rs. 135.00 -do-

189. -do- Vegatob Ear Drops.Each ml Contains:-Tobramycin………………….3mg.Dexamethasone Sodium Phosphate……………1mg.

5ml Rs. 125.00 -do-

190. M/s. Mass Pharma,Lahore.

Acless Cream.Each Tube Contains:-Clindamycin as Phosphate…..1% w/wTretinoin……………….0.05% w/w

20gm Rs. 500.00 Rejected as the firm did not apply

of form 5-D.

191. -do- Synalar Lotion.Each Tube Contains:-Flucinolone Acetonide..0.025% w/w

30ml Rs. 84.00 Rejected as the firm did not apply

of form 5-D.

192. -do- Hyseke Solution.Each Bottle Contains:-Ketoconazole……………2% w/w.


193. M/s. Akson Pharmaceuticals,Azad Kashmir.

D-Pain SR-100 Capsule.Each Capsule Contains:-Diclofenac Sodium Pellets….100mg.

2x10’s Rs. Rejected as the Renewal of the

firm is pending on its part.

194. -do- Hemitose-Plus Tablets.Each Tablet Contains:-Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron……………100mg.Folic Acid…………………0.35mg.

1x10’s Rs. 75.00 -do-

195. M/s. CCL Pharmaceuticals.

Lahore.

Ezestatin Tablets 1.1mg.Each Tablet Contains:-Ezetimibe…………………10mg.Atorvastatin……………….10mg.

10’s Rs. 330.50 Rejected as the renewal of the firm


196. -do- Ezestatin Tablets 1.2mg.Each Tablet Contains:-Ezetimibe…………………10mg.Atorvastatin……………….20mg.

10’s Rs. 666.98 -do-

197. -do- Ezestatin Tablets 1.4mg.Each Tablet Contains:-Ezetimibe…………………10mg.Atorvastatin……………….40mg.

10’s Rs. 998.97 -do-

198. -do- Vastim 10/10 Tablets.Each Tablet Contains:-Ezetimibe………………….10mg.Simvastatin………………...10mg.

10’s As per Brand

Leader.

-do-


10’s As per Brand

Leader.

-do-


10’s As per Brand

Leader.

-do-

201. M/s. Scotmann Pharmaceuticals,

Islamabad.

Direct-H Tablets.Each Tablet Contains:-Candesartan Cilexetil………..16mg.Hydrochlorothiazide……..12.5mg.

28’s Rs. 25.00/ Tablet.

Approved*

202. -do- Fersip Syrup.Each 5ml contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron.....................50mg.

60ml120ml250ml

Rs. 119.40Rs. 190.91Rs. 359.00

-do-

203. -do- Fersip Drops.Each ml Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron........................50mg.

30ml Rs. 170.00 -do-

204. M/s. Werrick Pharmaceuticals,

Islamabad.

Cardiovasc Plus Tablets.Each Tablet Contains:-Amlodipine as Besylate……….5mg.Atorvastatin as Calcium……….10mg.

10’s14’s

Rs. 34.50/ Tablet.

Approved*/ Installation and verification of

HVAC system in the firm.

205. -do- Ferick Chewable Tablets.Each Tablet Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron........................100mg.

20’s Rs. 9.75 -do-

206. -do- Ageon Tablets 10mg.Each Tablet Contains:-Rosuvastatin as Calcium………10mg.

14’s28’s

Rs. 71.89/ Tablet.

-do-


14’s28’s

Rs. 116.6/ Tablet.

-do-


14’s28’s

Rs. 116.6/ Tablet.

-do-

209. -do- Ferick Drops.Each ml contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron.........................50mg.

30ml Rs. 170.00 -do-

210. -do- Ferick Syrup.Each 5ml Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron.........................50mg.

60ml120ml250ml

Rs. 119.40Rs. 190.91Rs. 359.00

-do-

211. -do- Softin-P Tablets.Each Tablet Contains:-Losartan Potassium……………5mg.Pseudoephedrine Sulphate……120mg

14’s Rs. 25.00/ Tablet.

-do-

212. -do- Weight-ON Syrup.Each 5ml Contains:-Pizotifen (as Hydrogen Maleate)…….…0.25mgThiamine HCl……………….0.875mgRiboflavin-5-Phosphate Na….1.31mgPyridoxine HCl…………….0.77mg.Nicotinamide………………5.25mg

60ml120ml

Rs. 58.94Rs. 83.99

Rejected as the drug is not required

in applied indication.

213. M/s. Wilson’s Pharmaceuticals,

Islamabad.

Dayon-H Tablets.Each Tablet Contains:-Candesartan Cilexetil……….16mg.Hydrochlorothiazide……….12.5mg.

28’s Rs. 25.00/ Tablet.


HVAC system in the section,

214. -do- Talergin-P Tablets.Each Tablet Contains:-Loratadine………………….5mg.Pseudoephedrine Sulphate…..120mg.

14’s Rs. 25.00/ Tablet.

Approved*/ comparison of

dissolution profile with the originator.

215. -do- Glade Tablets.Each Tablet Contains:-Glucosamine Sulphate……..500mg.Chondroitin Sulphate………400mg.Vitamin C……………………25mg.Calcium Carbonate………….75mg.

20’s Rs. 16.00/ Tablet.

Rejected being an irrational

combination.

216. -do- Pain-Nil MR Tablets.Each Tablet Contains:-Ibuprofen……………………300mg.Codeine Phosphate Hemi hydrate………………..20mg.

100’s Rs. 7.00/ Tablet.

Rejected as the firm did not apply

on form 5-D.

217. -do- Pain-Nil Tablets.Each Tablet Contains:-Ibuprofen…………………200mg.Codeine PhosphateHemi hydrate…………….12.8mg.

100’s Rs. 3.00/ Tablet.

-do-

218. -do- Sofvasc Plus Tablets 5mg/10mg.Each Tablet Contains:-Amlodipine as Besylate………5mg.Atorvastatin as Calcium………10mg.

10’s14’s

Rs. 34.50/ Tablet.



219. -do- Ferwil Chewable Tablets.Each Tablet Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron........................100mg.

20’s Rs. 9.75/ Tablet.

-do-

220. -do- Ferwil Syrup.Each 5ml Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron......................50mg

60ml120ml250ml

Rs. 119.40Rs. 190.91Rs. 359.00

-do-

221. -do- Ferwil Drops.Each ml Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron............50mg

30ml Rs. 170.00 -do-


Lahore.

Filgras Injection.Each ml vial contains:-Filgrastim…………………300mcg.

1’s 5% less than brand

leader.

Approved*/ submission of the

source of raw material.

223. -do- Zolin-250 Injection.Each vial contains:-Cefazolin as Cefazolin Sodium…………….250mg

1’s -do- Approved*

224. -do- Zolin-500 Injection.Each vial contains:-Cefazolin as Cefazolin Sodium…………….500mg

1’s -do- -do-

225. -do- Zolin-1000 Injection.Each vial contains:-Cefazolin as Cefazolin Sodium……………1000mg

1’s -do- -do-

226. -do- Paclitax-100 Injection.Each 16.7ml vial contains:-Paclitaxel……………………100mg.

1’s Rs. 1450/ vial.

Approved*/ submission of the

source of Raw material.

227. -do- Paclitax-150 Injection.Each vial contains:-Paclitaxel……………………150mg.

25ml Rs. 21,375/ vial

-do-

228. M/s. Mass Pharmaceuticals,

Lahore.

Nilban Capsule 5mg.Each Capsule Contains:-Tropisetron Hydrochloride……5mg.




229. -do- Nilban Injection 5mg/5ml.Each 5 ml vial contains:-Tropisetron Hydrochloride……5mg.

5ml Rs. 1200.00.

-do-

230. M/s. PDH Pharmaceuticals,

Lahore.

Calcium-P Chewable Tablets.Each Tablet Contains:-Elemental Calcium………..400mg.Vitamin D………………..5mcg.

30’s Rs. 70.00 Approved*/ Installation and verification of


231. M/s. Global Pharmaceuticals,

Islamabad.

Gloserine Tablets.Each Tablet Contains:-D-Cyclosrine………………250mg.

14’s As per SRO


on form 5-D.

232. M/s. Martin Dow Pharmaceuticals,

Lahore.

Anorex Syrup.Each 5ml Contains:-Cyproheptadine HCl………..1.5mg.L-Carnitine………………….150mg.+ lycine & vitamine B1, B6 and B12.

60ml90ml120ml240ml

Rs. 84.00Rs. 117.00Rs. 144.00Rs. 240.00

Rejected being an irrational

combination.

233. -do- Valentin Syrup.Each 5ml Contains:-Gabapentin………………….250mg.

60ml120m

Rs. 420.00Rs. 768.00

Rejected as the drug in said

formulation is not Registered by FDA and UK and show cause notices shall

be issued to the firms already got the Registration.

234. -do- Lefloril Tablets 10mg.Each Tablet Contains:-Leflunomide………………….10mg.

10’s30’s

Rs. 145.00Rs. 405.00



235. -do- Lefloril Tablets 20mg.Each Tablet Contains:-Leflunomide………………….20mg.

10’s30’s

Rs. 265.00Rs. 765.00

-do-

236. -do- Valentin Tablets 100mg.Each Tablet Contains:-Gabapentin…………………..100mg.

10’s30’s

Rs. 150.00Rs. 420.00


on form 5-D.


10’s30’s

Rs. 300.00Rs. 840.00

-do-


10’s30’s

Rs. 450.00Rs.1260.00

-do-

239. -do- Estera capsules 75mg.Each Capsule Contains:-Pregabalin…………………….75mg.

14’s30’s

Rs. 1344.00

Rs. 2820.00



240. -do- Estera capsules 150mg.Each Capsule Contains:-Pregabalin………………….150mg.

14’s30’s

Rs. 1988.00

Rs. 4200.00

-do-

241. M/s. Nimrall Laboratories,

Rawat.

Maxi-15 Tablets.Each Tablet Contains:-Meloxicam……………………15mg.

1x10’s As per SRO

Approved*

242. -do- Maxi-30 Tablets.Each Tablet Contains:-Meloxicam…………………...30mg.

1x10’s -do- Rejected as the firm did not apply

on form 5-D

243. -do- Mflox Tablets.Each Tablet Contains:-Moxifloxacin…………………400mg.


244. -do- Twist SR Capsules.Each capsule Contains:-Diclofenac Sodium (as Pellets)…………100mg.

1x10’s -do- -do-/ comparison of dissolution studies with the originator.


Islamabad.

Nasta Tablets.Each Tablet Contains :-Nimesulide............................100mg.

10’s Rs. 100.00 Deferred.

246. -do- Lovast Tablets.Each Tablet Contains :-Atorvastatin…………………10mg.


247. -do- Lovast Tablets 20mg.Each Tablet Contains :-Atorvastatin...........................20mg.

10’s Rs. 350.00 -do-

248. -do- Breez Tablets 10mg.Each Tablet Contains :-Montelukast as Sodium..........10mg.

14’s Rs. 220.00 -do-

249. -do- Painex Tablets.Each Tablet Contains:-Piroxicam as Beta cyclo dextrin……………………20mg.

20’s Rs. 160.00 -do-

250. -do- Rcam Tablets.Each Tablet Contains:-Meloxicam…………………15mg.

10’s Rs. 59.50 -do-

251. -do- Efficent Tablets.Each Tablet Contains:Ebastine……………………10mg.

10’s Rs. 95.00 -do-

252. -do- Teza Tablets.Each Tablet Contains:-Tizanidine as HCl……………2mg.

10’s Rs. 115.00 -do-

253. -do- Skelam-20 Capsules.Each Capsule Contains:-Piroxicam……………………20mg.

20’s Rs. 127.92 -do-

254. -do- Fluxent Capsules.Each Capsule Contains:-Fluoxetine HCl…………….20mg.

14’s Rs. 449.82 -do-

255. -do- Diclopan Capsules.Each Capsule Contains:-Diclofenac Sodium Pellets…..75mg.

20’s Rs. 250.00 -do- / comparison of the dissolution profile with the

originator256. -do- Irosoft Capsules.

Each Capsule Contains:-Iron III Hydroxide Polymaltose Complex eq. to Elemental Iron……………...100mg.

1x10’s Rs. 150.00 Deferred subject to the submission of

international availability.

257. M/s. Synchro Pharmaceuticals,

Lahore.

Sporocef Injection 250mg.Each Vial Contains:-Cefotaxime……………..250mg.


258. -do- Sporocef Injection 500mg.Each Vial Contains:-Cefotaxime……………..500mg.

1’s Rs. 145.00 -do-

259. -do- Chrocef Injection 1gm.Each Vial Contains:-Cephradine………………...1000mg.

1’s Rs. 92.00 -do-

260. -do- Chrocef Injection 250mg.Each Vial Contains:-Cephradine………………...250mg.

1’s Rs. 37.00 -do-

261. -do- Pirocef Injection.Each Vial Contains:-Cefpirome…………………500mg.

1’s Rs. 241.00 -do-

262. -do- Trucef Injection 250mg.Each Vial Contains:-Cefuroxime……………….250mg.

1’s Rs. 240.00 -do-

263. -do- Trucef Injection 1500mg.Each Vial Contains:-Cefuroxime……………….1500mg.

1’s Rs. 234.00 -do-

264. -do- Ceftizime Injection.Each Vial Contains:-Ceftizoxime………………..500mg.

1’s Rs. 119.00 -do-

265. -do- Synozol Injection 250mg.Each Vial Contains:-Cefazoline………………….250mg.

1’s Rs. 42.00 -do-


1’s Rs. 42.00 -do-


1’s Rs. 115.00 -do-

268. -do- Taxocyn Injection 500mg.Each Vial Contains:-Ceftriaxone……………..500mg.

1’s Rs. 243.00 -do-

269. -do- Taxocyn Injection 2000mg.Each Vial Contains:-Ceftriaxone……………..2000mg.

1’s Rs. 1112.00

-do-

270. -do- Flexin Suspension 125mg.Each 5ml Contains:-Cephalexin……………….125mg.

60ml Rs. 54.00 -do-.

271. -do- Flexin Suspension 250mg.Each 5ml Contains:-Cephalexin……………….250mg.

60ml Rs. 89.00 -do-

272. -do- Clorocef Suspension 250mg.Each 5ml Contains:-Cefaclor……………………..250mg.

60ml Rs. 329.25 -do-

273. -do- Cetizime Injection.Each Vial Contains:-Ceftizoxime…………………250mg.

1’s Rs. 66.00 -do-

274. -do- X-Act Injection.Each Vial Contains:-Ceftazidime…………………500mg.

1’s Rs. 221.02 -do-

275. -do- Cefobact Injection.Each Vial Contains:-Cefoperazone………………1000mg.Sulbactum………………….1000mg.

1’s Rs. 682.00 -do-

276. -do- Synopime Injection.Each Vial Contains:-Cefepime HCl…………..500mg.

1’s Rs. 391.00 -do-

277. -do- Ceftixime Injection.Each Vial Contains:-Ceftizoxime……………….1000mg.

1’s Rs. 233.00 -do-

278. M/s. Pulse Pharmaceuticals,

Lahore.

Cafmol Tablets.Each Tablet Contains :-Paracetamol………………..500mg.


279. -do- P-Mol Tablets.Each Tablet Contains:-Paracetamol…………………500mg.

20x10’s Rs. 500.00 Rejected as the firm has submitted two Registration files for the same

generic .280. -do- Cafmol Plus Tablets.

Each Tablet Contains :-Paracetamol………………..500mg.Caffeine……………………65mg.


281. -do- Oxopulse Tablets.Each Tablet Contains:-Ofloxacin…………………..200mg.

10’s Rs. 150.00 -do-

282. -do- Oxopulse Tablets.Each Tablet Contains:-Ofloxacin…………………..400mg.

10’s Rs. 250.00 -do-

283. -do- Erythiropulse Suspension.Each 5ml Contains:-Erythromycin………………125mg.

60ml Rs. 36.00 Rejected as the firm has no section.

284. -do- Erythiropulse Tablets.Each Tablet Contains:-Erythromycin………………500mg.

10x10’s Rs. 450.00 Rejected being incomplete application.

285. M/s. Webrose Pharmaceuticals,

Islamabad.

Karizma Tablets 20mg.Each Tablet Contains:-Esomeprazole as Magnesium Trihydrate……….20mg.

2x7’s Rs.200.00 Approved*

286. -do- Karizma Tablets 40mg.Each Tablet Contains:-Esomeprazole as Magnesium Trihydrate……….40mg.

2x7’s Rs. 323.00 -do-

287. -do- Aclare Tablets 200mg.Each Tablet Contains:-Ribavirin………………….200mg.

10’s Rs. 250.00 -do-


10’s Rs. 480.00 -do-


10’s Rs. 570.00 -do-


10’s Rs. 650.00 -do-

291. -do- Ocify Tablets.Each Tablet Contains:-Lansoprazole………………30mg.

2x7’s Rs. 206.00 -do-

292. -do- Krestor Tablets 5mg.Each Tablet Contains:Rosuvastatin………………..5mg.

10’s Rs. 100.00 -do-


10’s Rs. 180.00 -do-


10’s Rs. 360.00 -do-

295. -do- Glored Tablets.Each Tablet Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron.....................100mg.Folic Acid............................0.75mg.

10’s Rs. 72.00 Rejected as the firm did not apply

on form 5-D.

296. -do- Estomac Tablets.Each Tablet Contains:-Omeprazole………………..20mg.


297. -do- Perk Tablets.Each Tablet Contains:-Pentoprazole as Sodium Sesquihydrate……………..40mg.

2x7’s Rs. 310.00 -do-

298. M/s. CCL, Pharmaceuticals,

Lahore.

Cyclozine Tablets.Each Tablet Contains:-Cyclobenzaprine HCl……….10mg.


leader



299. -do- Cyclozine Tablets.Each Tablet Contains:-Cyclobenzaprine HCl……….5mg.


leader

-do-


Vassodip Tablets 5mg/10mg.Each Tablet Contains:-Amlodipine as Besylate………5mg.Atorvastatin as Calcium………10mg.


Approved*

301. -do- Vassodip Tablets 5mg/20mg.Each Tablet Contains:-Amlodipine as Besylate………5mg.Atorvastatin as Calcium………20mg.


-do-

302. M/s. Amson Vaccine & Pharma,Islamabad.

Simatin-E 10/10 Tablets.Each Tablet Contains:-Ezetimibe……………………10mg.Simvastatin………………….10mg.

1x10’s As per SRO

-do-

303. -do- Simatin-E 10/20 Tablets.Each Tablet Contains:-Ezetimibe……………………10mg.Simvastatin………………….20mg.

1x10’s As per SRO

-do--


1x10’s As per SRO

-do-


1x10’s As per SRO

-do-

306. M/s. Shaigan Pharmaceuticals,

Rawalpindi.

Tramad-50 SR Capsule.Each Capsule Contains:-SR pellets eq. to Tramadol HCl………………….50mg.

1x10’s ---- Rejected as the drug in the said strength is not

Sustained release dosage form.

307. -do- Tramad-100 SR Capsule.Each Capsule Contains:-SR pellets eq. to Tramadol HCl……………….100mg.

1x10’s ---- Approved*/ installation and finalization of

HVAC system in the section/

comparison of dissolution profile

with originator.308. M/s. Amson Vaccine

& PharmaIslamabad.

Atropine Tablet 5/40mg.Each Tablet Contains:-Atorvastatin (as Calcium)……..40mg.Amlodepine (as Besylate)……5.00mg

2x10’s Rs. 837.00 Approved*/ change of name

309. -do- Atropine Tablet 10/10mg.Each Tablet Contains:-Atorvastatin (as Calcium)……..10mg.Amlodepine (as Besylate)……10mg

2x10’s Rs. 382.00 -do-


2x10’s Rs. 565.00 -do-


2x10’s Rs. 931.00 -do-

312. M/s. Lawrence Pharma,Lahore.

Licaine injection.Each Vial Contains:-Lignocaine HCl……………2%w/v

100x2ml50x10ml

Rs. 160.00Rs. 531.16

Approved*

313. -do- Licaine injection.Each Vial Contains:-Lignocaine HCl……………2%w/vAdrenaline BP…………1:100000

100x2ml50x10ml

Rs. 225.00Rs. 631.16

-do-

314. -do- Lawrcobolomin Injection.Each Vial Contains:-Mecobalamin BP…………….500mcg

10x1ml Rs. 460.00 -do-

315. -do- Cyanocobalamine Injection.Each 2ml Contains:-Cyanocobalamine BP……….500mcg.

1x100 Amp.

2x25 Amp.

Rs. 175.00Rs. 63.00

-do-

316. -do- Lawrzol Injection.Each 100ml Contains:-Metronidazole ………………500mg.

1x100ml Rs. 60.00 -do-

317. M/s. CSH, Pharmaceuticals,

Peshawar.

Omecare Capsules 20mg.Each Capsule Contains:-Omeprazole……………….20mg.

2x7’s Rs. 10.00/ Capsule.

-do-

318. -do- Omecare Capsules 40mg.Each Capsule Contains:-Omeprazole……………….40mg.

2x7’s Rs. 252.00 -do-

319. -do- Hb-Rise Chewable Tablets 100mg.Each Chewable Tablet Contains:-Iron III Hydroxide Polymaltose Complex eq. to Elemental iron………………100mg

2x10’s Rs. 150.00 -do-

320. -do- Hb-Rise Plus Chewable Tablets.Each Chewable Tablet Contains:-Iron III Hydroxide Polymaltose Complex eq. to Elemental iron………………100mgFolic Acid…………………..0.35mg

2x10’s Rs. 150.00 -do-

321. -do- Betacam 20 Tablets.Each tablet contains:-Piroxicam as B-cyclodextrin…..20mg.

2x10’s Rs. 165.00 -do-

322. -do- Hb-Rise Syrup.Each 5ml Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron...................50mg.

60ml Rs. 90.00 -do-

323. -do- Hb-Rise Drops.Each ml Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron....................50mg.

30ml Rs. 120.00 -do-

324. M/s. Wel Mark Pharmaceuticals,

Hattar.

Lanzole Injection 30mg.Each 10ml Contains:-Lansoprazole……………….30mg.


Approved*

325. -do- GoAcid Injection.Each 10ml Contains:-Omeprazole…………………40mg.

1’s -do- -do-

326. -do- Melcar Injection 40mg.Each 10ml Contains:-Esomeprazole……………….40mg.

1’s -do- -do-

327. M/s. Orta Laboratories,

Lahore.

Floro Tablets.Each Tablet Contains:-Flurbiprofen……………….100mg.

3x10’s As per leader price.

-do-

328. -do- Neporex Tablets.Each Tablet Contains:-Naproxen Sodium…………..550mg.

2x10’s -do- -do-

329. -do- Orpram Tablets.Each Tablet Contains:-Escitalopram……………….10mg.

14’s -do- -do-

330. -do- Diclo-K Tablets.Each Tablet Contains:-Diclofenac Potassium…………50mg.

10’s -do- -do-

331. -do- Ortabolamin Tablets.Each Tablet Contains:-Mecobalamine………………500mcg.

10x10’s -do- -do-

332. -do- Moflox Tablets.Each Tablet Contains:-Moxifloxacin……………….400mg.

10’s -do- -do-

333. -do- Ortafer Plus Tablets.Each Tablet Contains:-Iron III Hydroxide Polymaltose Complex……………………100mg.Folic Acid…………………..0.35mg.

10’s -do- -do-

334. -do- Aether Capsules.Each Capsule Contains:-Artemether…………………..40mg.

10’s -do- Rejected as the single ingredient

therapy of the antimalarial is not

required.335. -do- Maladol Capsule.

Each Capsule Contains:-Tramadol BP…..……………50mg.

10’s -do- Rejected as per policy the firm does not have

dedicated facility for psychotropic

section.336. -do- Ortabolamin Injection.

Each vial contains:-Mecobalamin………………500mcg.


337. -do- Ortafer Plus Syrup.Each Syrup Contains:-Iron III Hydroxide Polymaltose Complex……………………100mg.Folic Acid…………………..0.35mg.

60ml -do- -do-

338. M/s. Paktex Industries,Kamoke.

Absorbent Cotton Gauze.Contains:-Cotton.

1m x 1m1m x 10m1m x 40m1m x 50m1m x 2.5m

Not mention.



339. -do- Pak Optic (eye pads).Contains:-Cotton, Cloth.

5cmx7.5cm6cmx8.0cm

Rs. 124.00Rs. 154.00

-do-

340. M/s. Alson Pharmaceuticals,

Peshawar.

Alpoly Tablets.Each Tablet Contains:-Iron III Hydroxide Polymaltose Complex eq. To Elemental Iron (M.S)...............100mg.

Not mentioned.

Rs. 9.00/ Tablet.

Approved*

341. LCPW, Lahore Hyospan P Tablets.Each enteric coated tablet contains:-Hyoscine N butylbromide………10mg.Paracetamol…………………..500mg.

100’s Rs. 145/ Tablet.



342. Medipak Limited, Lahore.

Dortim Eye Drops.Each ml contains:-Dorzolamide as HCl………..20mg.Timolo as Maleate USP……5mg.

5ml Rs. 962.00 Rejected as the renewal of the firm


343. -do- Ketomed Eye Drops.Each ml contains:-Ketotifen as Fumarate……….05mg

5ml Rs. 606.32 -do-

344. -do- Oflomed-D Eye Drops.Each ml contains:-Ofloxacin USP………………..3mg.Dexamethasone as Sodium Phosphate USP………1mg.

5ml Rs. 100.00 -do-

345. -do- Moxiquin Eye Drops.Each ml contains:-Moxifloxacin as HCl………….5mg.

5ml Rs. 425.00 -do-

346. -do- Oflomed Eye Drops.Each ml contains:-Ofloxacin USP………………….3mg.

5ml Rs. 91.61 -do-


Islamabad.

Lansozef Capsules.Each Capsule contains:-Lansoprazole…………………30mg.


348. -do- Pyrox Tablets.Each tablet contains:-Piroxicam as B-cyclodextrin….20mg.

20’s Rs. 250.00 -do-

349. -do- Tizen Tablets.Each tablet contains:-Tizanidine HCl……………….2mg.

10’s Rs. 130.00 -do-

350. -do- Alfazef Tablets.Each tablet contains:-Alfacalcidol………………..0.5mcg.

20’s Rs. 300.00 Approved*/ submission of

content uniformity of the product.

351. M/s Al-Shifa Pharmaceuticals,

Rawalpindi.

Chlorodex Eye Drops.Chloremphenicol……………0.5%.Dexamethasone as Sodium Phosphate………….0.1%.


352. -do- Shifeye Eye Drops.Tobramycin………………0.3%.Dexamethasone as Phosphate….0.1%.

5ml Rs. 120.00 -do-

353. M/s Pacific Pharmaceuticals,

Lahore.

Fero-Plus Chewable Tablets.Each Tablet Contains:-Vitamin C………………….30mg.Ferrous Fumarate…………..7mg.Copper…………………….0.4mg.Folic Acid………………100mcg.

20’s30’s

Not mention.


on form 5-D

354. -do- Vital Tablets.Each Tablet Contains:-Vitamin E (d-alpha tocopheryl acetate)……30mg.Vitamin C (i-ascorbic acid)……600mg.Folic Acid……………………...400mcgNiacinamide…………………100mg.Pyridoxine HCl…………………5mg.Cyanacobalamin……………12mcg.Biotin………………………..45mcgCalcium pantothenate…………25mg.Copper (as cupric oxide)………3mg.Zinc (as zinc sulphate)…………23.9mgVitamin B1 (Thiamin mononitrate)…………………20mg.Vitamin B2 as Riboflavin………10mg.

3x10’s10x10’s

Rs. 80.00Rs.260.00

Rejected as the firm has quoted the wrong reference of the me-too product

in Registration dossier.

355. M/s. Tagma Pharmaceuticals,

Lahore.

Tagacef Dry Suspension.Each 5ml Contains:-Cephradine …………………..125mg.

60ml Rs. 70.00 Approved*/ Installation and verification of


356. -do- Duet Dry Suspension.Each 5ml Contains:-Cefixime……………………..200mg.

30ml Rs. 300.00 -do-

357. M/s. Werrick Pharmaceuticals,

Islamabad.

Pentin Tablets 100mg.Each Tablet Contains:-Gabapentin…………………..100mg.



on form 5-D.

358. -do- Pentin Tablets 300mg.Each Tablet Contains:-Gabapentin…………………..300mg.

10’s Rs.18.9/ Tablet.

-do-

359. -do- Pentin Tablets 400mg.Each Tablet Contains:-Gabapentin………………..400mg.


-do-

360. -do- Co-Lispril Tablets 20/12.5mgEach Tablet Contains:-Lisinopril…………………….20mg.Hydrochlorothiazide………..12.5mg.

14’s Rs. 22.92 Approved*/ installation and verification of


361. -do- Captil-H Tablets 50/25mg.Each Tablet Contains:-Captopril………………………50mg.Hydrochlorothiazide…………..25mg.

20’s Rs. 14.87 -do-

362. M/s Trigon Pharmaceutical,

Lahore.

Pantagon Injection IM/IV.Each 1ml ampoule contains:-Pentazocine as Lactated…….30mg.

1ml As per SRO

Approved*

363. -do- Bubrifen Injection.Each ml contains:-Buprenorphine as HCl……..03mg.

1ml As per SRO

-do-

NEW LICENSE.



Proposed Price

Remarks

364. M/s. Hisun Pharmaceuticals,

Swabi.

Levanic Tablets 250mg.Each Tablet Contains:-Levofloxacin as Hemihydrate….250mg.

Not mention. As per SRO

Approved*

365. -do- Levanic Tablets 500mg.Each Tablet Contains:-Levofloxacin as Hemihydrate….500mg.

-do- -do- -do-

366. -do- Cipral Tablets 250mg.Each Tablet Contains:-Ciprofloxacin as HCl…………250mg.

-do- -do- -do-

367. -do- Cipral Tablets 500mg.Each Tablet Contains:-Ciprofloxacin as HCl…………500mg.

-do- -do- -do-

368. -do- Clarin Tablets 250mg.Each Tablet Contains:-Clarithromycin……………….250mg.

-do- -do- -do-

369. -do- Clarin Tablets 500mg.Each Tablet Contains:-Clarithromycin……………….500mg.

-do- -do- -do-

370. -do- Roxim Tablets 150mg.Each Tablet Contains:-Roxithromycin……………….150mg.

-do- -do- -do-

371. -do- Oflovid Tablets 200mg.Each Tablet Contains:-Ofloxacin……………………200mg.

-do- -do- -do-

372. -do- X-Cid Tablets.Each Tablet Contains:-Famotidine………………..40mg.

-do- -do- -do-

373. -do- Di-K Tablets.Each Tablet Contains:-Diclofenac Potassium…………50mg.

-do- -do- -do-

374. -do- NT Mic Capsules.Each Capsule Contains:-Iron Polymaltose eq. to Iron……100mg.Folic Acid…………………….0.35mg.

-do- -do- Deferred for submission of international availability.

375. -do- Esozole Capsules 20mg.Each Capsule Contains:-Esomeprazole………………..20mg.

-do- -do- Approved*

376. -do- Esozole Capsules 40mg.Each Capsule Contains:-Esomeprazole………………..40mg.

-do- -do- -do-

377. -do- Lansozol Capsules 15mg.Each Capsule Contains:-Lansoprazole…………………15mg.

-do- -do- -do-

378. -do- Lansozol Capsules 30mg.Each Capsule Contains:-Lansoprazole…………………30mg.

-do- -do- -do-

379. -do- Bona-Alpha Capsules.Each Capsule Contains:-Alfacalcidol…………………..1mcg.

-do- -do- -do-/ submission of

content uniformity

testing.380. -do- Omepip Capsules.

Each Capsule Contains:-Omeprazole………………….20mg.

-do- -do- Approved*

381. -do- Meco-12 Capsules.Each Capsule Contains:-Mecobalamin…………………500mcg.

-do- -do- -do-

382. -do- Multivit Capsules.Each Capsule Contains:-Vitamin A………………….5500unitsVitamin D………………….500units.Vitamin E………………….10mg.Vitamin B12........................8mcg.Folic Acid............................200mcg.Thiamin HCl………………10mg.Riboflavin………………….10mg.Pyridoxine HCl……………..5mgNicotinamide………………30mg.Ascorbic Acid………………100mg.Calcium-d-Pantothenate…….20mg.

-do- -do- Deferred for policy

383. -do- Felvit Capsules.Each Capsule Contains :-Iron Polymaltose eq. to Iron…..100mg.Folic Acid……………………..0.5mg.Thiamin HCl………………….2mg.Riboflavin…………………….2mg.Pyridoxine HCl……………….1mg.Nicotinamide………………….10mg.Ascorbic Acid…………………50mg.

-do- -do- -do-

384. -do- Cefatrin Capsules 250mg.Each Capsule Contains:-Cefatrizine……………………250mg.

-do- -do- Approved*

385. -do- Cefatrin Capsules 500mg.Each Capsule Contains:-Cefatrizine……………………500mg.

-do- -do- -do-

386. -do- Hiflex Capsules 250mg.Each Capsule Contains:-Cephalexin as HCl…………250mg.

-do- -do- -do-

387. -do- Hiflex Capsules 500mg.Each Capsule Contains:-Cephalexin as HCl…………500mg.

-do- -do- -do-

388. -do- Cefride Capsules 250mg.Each Capsule Contains:-Cephradine…………………….250mg.

-do- -do- -do-

389. -do- Cefride Capsules 500mg.Each Capsule Contains:-Cephradine…………………….500mg.

-do- -do- -do-

390. -do- Cefixun Capsules.Each Capsule Contains:-Cefixime………………………400mg.

-do- -do- -do-

391. -do- Cefdrox Capsules 500mg.Each Capsule Contains:-Cefadroxil.................................500mg.

-do- -do- -do-

392. -do- Samoclor Capsules 500mg.Each Capsule Contains :-Cefaclor.......................................500mg.

-do- -do- -do-

393. -do- Safenar Capsules 100mg.Each Capsule Contains:-Cefdinir………………………..100mg.

-do- -do- -do-

394. -do- Cefride Dry Suspension 125mg.Each 5ml Contains:-Cephradine………………..125mg.

-do- -do- -do-

395. -do- Cefride Dry Suspension 250mg.Each 5ml Contains:-Cephradine………………..250mg.

-do- -do- -do-

396. -do- Cefdrox Dry Suspension 125mg.Each 5ml Contains:-Cefadroxil……………………..125mg.

-do- -do- -do-

397. -do- Cefdrox Dry Suspension 250mg.Each 5ml Contains:-Cefadroxil……………………..250mg.

-do- -do- -do-

398. -do- Hiflex Dry Suspension 125mg.Each 5ml Contains:-Cephalexin…………………125mg.

-do- -do- -do-

399. -do- Hiflex Dry Suspension 250mg.Each 5ml Contains:-Cephalexin…………………250mg.

-do- -do- -do-

400. -do- Cefatrin Dry Suspension 250mg.Each 5ml Contains:-Cefatrizine………………….250mg.

-do- -do- -do-

401. -do- Safenar Dry Suspension 50mg.Each 5ml Contains:-Cefidinir…………………50mg.

-do- -do- -do-

402. -do- Cefurim Dry Suspension 125mg.Each 5ml Contains:-Cefuroxime………………125mg.

-do- -do- -do-

403. -do- Cefixun Dry Suspension 100mg.Each 5ml Contains:-Cefixime as Trihydrate………..100mg.

-do- -do- -do-

404. -do- Hidryll Syrup.Each 5ml Contains:-Ammonium Chloride………….30mg.Aminophyline…………………32mg.Diphenhydramine HCl…………8mg.Menthol………………………..0.98mg.

-do- -do- -do-

405. -do- Hidryll-DM Syrup.Each 5ml Contains:-Dextrometharphan HBr……….6.25mg.Diphenhydramine HCl…………5mg.

-do- -do- -do-

406. -do- Panado-CF Suspension.Each 5ml Contains:-Paracetamol……………………80mg.Cholrpheniramine Maleate…….1mg.Pseudoephedrine HCl………….15mg.

-do- -do- -do-

407. -do- NTMic Syrup.Each 5ml Contains:-Iron Polymaltose eq. to Iron…….50mg.Folic Acid……………………0.35mg.

-do- -do- -do-

408. -do- Almacid Suspension.Each 5ml Contains:-Aluminum Hydroxide…………215mg.Magnesium hydroxide………….80mg.Simethicone…………………….25mg.

-do- -do- -do-

409. -do- X-Cid Suspension.Each 5ml Contains:-Famotidine……………………..10mg.

-do- -do- -do-

410. -do- Domec Suspension.Each 5ml Contains:-Domperidone…………………5mg.

-do- -do- -do-

411. -do- Predcort Syrup.Each 5ml Contains:-Prednisolone……………………15mg.

-do- -do- -do-

412. -do- Multivit Syrup.Each 5ml Contains:-Vitamin A……………….....…3000iu.Vitamin D……………….......…400iu.Cyanocobalamin(Vit B12)..........3mcg.Thiamin HCl (Vit B1)…………1.5mgRiboflavin (Vit B2)……………1.2mgPyridoxine HCl (Vit B6)………..1mg.Ascorbic Acid (Vit C)………….50mgNicotinamide……………………10mg.

-do- -do- Deferred for policy.

413. -do- Betaplex Syrup.Each 5ml Contains:-Thiamin HCl (Vit B1)……………10mgRiboflavin (Vit B2)……………….5mg.Pyridoxine HCl (Vit B6)…………2mg.Cyanocobalamin (Vit B12)……10mcgNicotinamide..............................20mg.Calcium-d-Pantothenate.............5mg.

-do- -do- -do-

414. -do- Fusicort Cream.Each Tube Contains:-Fusidic Acid………………….2%

-do- -do- Approved*

415. -do- Fusicort-H Cream.Each Tube Contains:-Fusidic Acid…………………….20mg.Hydrocortisone Acetate………..10mg.

-do- -do- -do-

416. -do- Dipravate Cream.Each Tube Contains:-Betamethasone Dipropionate…..0.05%

-do- -do- -do-

417. -do- Dipravate-G Cream.Each Tube Contains:-Betamethasone Dipropionate…....0.05%Gentamycin as Sulphate…………0.1%

-do- -do- -do-

418. -do- Betona-GM Cream.Each Tube Contains:-Betamethasone as Valerate………0.1%Gentamycin as Sulphate…………0.1%Miconazole Nitrate……………….2%

-do- -do- -do-

419. -do- Polybact Ointment.Each Gram Contains:-Polymyxin Beta Sulphate….10000unitBactitracin Zinc………………500unit.

-do- -do- -do-

420. -do- Ecotren Cream.Each Gram Contains:-Econazole Nitrate ……………..10mg.Triamcinolone Acetonide………1mg.Gentamycin As Sulphate ………1mg.

-do- -do- -do-

421. -do- Nitzone Cream.Each Tube Contains:-Nitrofunazone………………0.2%

-do- -do- -do-

422. -do- Gynim Cream.Each Tube Contains:-Clotrimazole……………………...1%

-do- -do- -do-

423. -do- Hysone Ointment.Each Tube Contains:-Hydrocortisone Acetate………..1% w/w

-do- -do- -do-

INCOMPLETE APPLICATIONS (REJECTED)



Proposed Price

Reasons

1. M/s. Munawar Pharmaceuticals,

Lahore.

Hyoscine Compound Tablets.Each Tablet Contains :-Hyoscine-N Butylbromide........10mg.Paracetamol...............................500mg


Physical parameters, pharmacopea reference, environment

al control procedures, facility of

water processing, signing of

pages, SOP’s & last

inspection report.

2. M/s. Olive Laboratories,Rawalpindi.

Amnidol Tablets.Each Tablet Contains:-Paracetamol………………..500mg.Diazepam………………….01mg.Chlorpheniramine Maleate…..2mg.

200’s Rs. 120.00 To Be rejected being an irrational

combination.

3. -do- Camnidol Tablets.Each Tablet Contains:-Paracetamol………………….500mg.Caffeine………………………65mg.Chlorpheniramine Maleate….2mg.

200’s Rs. 123.50 Pharmacological &

clinical data, physical

parameters, specification

s, pharmacopea reference, environment

al control procedures, facility of


pages, SOP’s, last inspection

report.4. M/s. Unison Chemical

Works.Lahore.

Kanstyl Tablets.Each Tablet Contains:-Clotrimazole…………………500mg.

1’s As per SRO Electronic copy,

physical parameters, specification

s, pharmacopea reference,

signing pages,

SOP’s, last inspection

report.5. M/s. Global

Pharmaceuticals,Islamabad.

Ribagene Tablets.Each Tablet Contains:-Ribavirin……………..400mg.(USP)

10’s Rs. 300.00 Physical parameters, specification


al control process,

facility of water

processing, SOP’s, last inspection

report.6. -do- Clopirine Tablets.

Each Tablet Contains:-Clopidogril……………………60mg.Aspirin………………………..25mg.(USP)

14’s As per SRO -do-/Two dosage forms are mentioned in form-5

7. M/s. Vision Pharmaceuticals,

Islamabad.

Azolam Tablets.Each Tablet Contains:-Alprazolam………………0.50mg.(USP)


Physical parameters, Environmental control process,

facility for water

processing,signing of

pages, SOP’s & cleaning validation,

last inspection report & master

formula.8. -do- Azolam Tablets.

Each Tablet Contains:-Alprazolam………………1mg.(USP)


-do-

9. -do- Azolam Tablets.Each Tablet Contains:-Alprazolam………………0.25mg.(USP)

30’s -do- -do-

10. -do- Deprogesic Tablets.Each Tablet Contains:-Dextropropoxyphene HCl…..32.5mg.Paracetamol…………………32.5mg.

100’s -do- To be rejected as

the products is already in

phase out process.

11. -do- Lexipam Tablets.Each Tablet Contains:-Bromazepam…………………3mg.(USP)

30’s -do- Physical parameters, Environmental control process,

facility for water

processing,signing of

pages, SOP’s & cleaning validation,

last inspection report & master formula

12. -do- Fingesic Injection.Each ampoule Contains:-Buprenorphine as HCl………..0.3mg.

5’s -do- -do-

13. -do- Nalgesic Injection.Each Ampoule Contains:-Nalbuphine HCl………………10mg.

10’s -do- -do-

14. -do- Zosine Injection.Each Ampoule Contains:-Pentazocine as Lactate ...…..30mg.(BP)

5’s -do- -do-

15. M/s. Mega Pharmaceuticals,

Lahore.

Zitamin Tablets.Each Tablet Contains:-Multivitamin with Minerals.

30’s As per SRO Strength of drug,


s, pharmacopea reference, facility of



inspection report.

16. -do- Zital Tablets.Each Tablet Contains:-Multivitamin with Iron.

30’s -do- -do-

17. -do- Zolic Capsules.Each Capsule Contains:-Ferrous Sulphate…………….150mgFolic Acid……………………0.5mg.

30’s -do- physical parameters, specification

s, pharmacopea reference, facility of



inspection report.

18. -do- Zenec Capsules.Each Capsule Contains:-Orlistat………………………120mg.

84’s As per SRO -do-

19. -do- Zalta Capsules 30mg.Each Capsule Contains:-Duloxetine …………………..30mg.

28’s -do- -do-

20. -do- Zapris Capsules.Each Capsule Contains:-Ziprasidone HCl…………….20mg.

60’s -do- -do-Strength of drug.

21. M/s. Lahore Chemical and Pharmaceuticals

Works.Lahore.

Safocin Syrup.Each 5ml Contains:-Fosfomycin BP…………….250mg.

60ml Rs. 11.25/5ml

Electronic copy,

composition, physical

parameters, specification


al control process,

facility of water

processing, SOP’s, last inspection

report.22. -do- Spaz Tablets.

Each Tablet Contains:-Drotaverine HCl……………..40mg.

Not mention. Rs. 2.25/ Tablet.

-do-

23. -do- Fast A Tablets.Each Tablet Contains:-Levocetirizine 2HCl………….5mg.

-do- Rs. 5.00/ Tablet.

-do-

24. -do- Nipro Tablets.Each Tablet Contains:-Naproxen Sodium eq. to Naproxen BP………………500mg.

-do- Rs. 8.00/ Tablet.

-do-

25. -do- Kelave Syrup.Each 5ml Contains:-Amoxicillin as Amoxicillin 3H2O BP………125mg.Clavulanic Acid as Pot Salt…31.25mg

60ml Rs. 4.25/5ml

-do-

26. M/s. Trigon Pharmaceuticals,

Lahore.

Mecobalamin Injection.Each ml Contains:-Mecobalamine…………….500mcg.

10 Amps. As per SRO Electronic copy,


s, type of container,

environmental control process,

facility of water

processing.27. -do- Fluend Tablets.

Each Tablet Contains:-Oseltamivir Phosphate USP…..75mg.

Not mentioned.

-do-

28. -do- Fluend Oral Suspension.Each ml Contains:-Oseltamivir Phosphate USP….12mg.

-do- -do-


Protopic Ointment.Each Tube Contains :-Tacrolimus MS…………….0.03%

5gm10gm

Rs.150.00Rs. 250.00

New application

form, physical

parameters, SOP’s

30. M/s. Usawa Pharmaceuticals,

Risalpur.

Cefariz Capsules.Each Capsule Contains :-Cephradine Compacted............250mg.

1x10’s As per SRO New application

form, physical

parameters, type of

container, environmtal

control process,

facility of water

processing, last

inspection report.

31. -do- Cefariz Capsules.Each Capsule Contains :-Cephradine Compacted............500mg.

2x6’s As per SRO -do-

32. M/s. Jawa Pharmaceuticals,

Lahore.

Artecure Capsules.Each Capsule Contains:-Artemether…………………40mg.

2x6’s Rs. 280.00 To be rejected as the single ingredient

antimalarial therapy is

not required.

33. -do- Esozole 20mg Capsules.Each Capsule Contains:-Esomeprazole asMagnesium Trihydrate…...........20mg.

14’s Rs. 170.00 Electronic copy,

physical parameters, specifications, technical

persons, SOP’s.

34. -do- Esozole 40mg Capsules.Each Capsule Contains:-Esomeprazole asMagnesium Trihydrate…...........40mg.

14’s Rs. 323.00 -do-

35. -do- Lecetzi Tablets.Each Tablet Contains:-Levocetirizine 2HCl………..5mg.

10’s Rs. 55.00 -do-

36. -do- Monkast Tablets.Each Tablet Contains:-Montelukast Sodium…………..5mg.

3x10’s Rs. 503.57 -do-

37. -do- Monkast Tablets.Each Tablet Contains:-Montelukast Sodium…………..10mg.

3x10’s Rs. 653.57 -do-

38. -do- Joxicam 7.5mg Tablets.Each Tablet Contains:-Meloxicam………………….7.5mg.

10’s Rs. 70.00 -do-

39. -do- Joxicam 15mg Tablets.Each Tablet Contains:-Meloxicam………………….15mg.

10’s Rs. 120.00 -do-

40. -do- Colorin Tablets.Each Tablet Contains:-Mebeverine HCl…………135mg.

3x10’s Rs. 205.95 -do-


Kasur.

Gabacid Capsules.Each Capsule Contains:-Gabapentin…………………100mg.

10’s Rs. 89.00 -do-

42. -do- Gabacid Capsules.Each Capsule Contains:-Gabapentin…………………300mg.

10’s Rs. 189.00 -do-

43. M/s. Arsons Pharmaceuticals ;

Lahore.

Super Absorbent Gauze.Contains :-Absorbent Gauze B.P.C.

90cmx2.5m Rs. 22.00 signing of pages, SOP’s, water

processing, undertaking,

44. -do- Master Crepe Bandage.Contains :-Crepe Bandage B.P.C.

5cmx2.5m Rs. 16.00 -do-

45. -do- Arsopas.Contains :-L-Menthol...........................36.32mg.Methyl salicylate.................29.98mg.Camphor..............................15.63mg.Thymol…………………….0.77mg.

10’s Rs. 15.00/ sachet.

Composition, brand names

available/companies in Pakistan, physical

parameters, specifications, signing of

pages, SOP’s, water


46. -do- Plaster Plus.Contains :-Plaster of Paris Bandage BPC.

7.5cmx2.5m Rs. 25.00 signing of pages, SOP’s, water


47. -do- Arsogaz Dressing.Contains :-Yellow Soft Paraffin

10cmx10cm Rs. 55.00 -do-

48. -do- Care Bandage.Contains:-Fabric.

5cmx2.5m6cmx2.5m

7.5cmx2.5m10cmx2.5m15cmx2.5m

Rs. 3.00Rs. 3.75Rs. 4.50Rs. 6.00Rs. 9.00

-do-

49. -do- Care Cotton.Contains:-Epidermal Trichomes.Cotton.

25gm. Rs. 9.00 -do-

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209th Meeting (R-II North)

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