6
DOSSIER LIST
DOSSIER LIST
C M Y CM MY
CY CMY
K
tlo_S
ELED
YN.p
df
1 2
2.08
.201
7 1
4:38
:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
ALIMENTARY TRACT & METABOLISM
1. Esomeprazole (sodium)
Powder for solution for infusion or injection 40 mg Nexium/
AstraZeneca Antiulcerant
2. Omeprazole Powder for solution for infusion 40 mg Losec/
AstraZeneca Antiulcerant
3. Orlistat OTC Capsules 60 mg Alli/GSK Obesity treatment
4. Orlistat Capsules 120 mg Xenical/Roche Obesity treatment
5.Pantoprazole (sodium sesquihydrate)
Powder for solution for injection 40 mg Pantozol/Altana Antiulcerant
6. Sitagliptin (hydrochloride) NEW! Film-coated tablets 25 mg | 50 mg | 100 mg Januvia/Merck Oral antidiabetic
7.Sitagliptin (hydrochloride) + Metformin NEW!
Film-coated tablets50 mg + 500 mg | 50 mg + 850 mg | 50 mg+ 1000 mg
Janumet/Merck Oral antidiabetic
ANTI-INFECTIVES FOR SYSTEMIC USE
8. Aciclovir Tablets 200 mg | 400 mg | 800 mg Zovirax/GSK Antiviral for systemic use
9. Clarithromycin Powder for solution for infusion 500 mg Klacid IV/Abbott Antibacterial for systemic use
10. Levofloxacin (hemihydrate) Film-coated tablets 250 mg | 500 mg Tavanic/Sanofi-
Aventis Antibacterial for systemic use
11. Levofloxacin (hemihydrate) Solution for infusion 5 mg/ml (100 ml) Tavanic/Sanofi-
Aventis Antibacterial for systemic use
12. Linezolid Film-coated tablets 600 mg Zyvox/Pfizer Antibacterial for systemic use
13. Linezolid Solution for infusion 2 mg/ml (300 ml) Zyvox/Pfizer Antibacterial for systemic use
14. Tenofovir disoproxil (fumarate) Film-coated tablets 245 mg Viread/Gilead
Science Antiviral for systemic use
15. Voriconazole Film-coated tablets 50 mg | 200 mg Vfend/Pfizer Antifungal for systemic use
BLOOD & BLOOD FORMING ORGANS
16. Rivaroxaban* NEW! Film-coated tablets 2.5 mg | 10 mg | 15 mg | 20 mg Xarelto/Bayer Oral anticoagulant
17. Ticagrelor** NEW! Film-coated tablets 60 mg | 90 mg Brilique/Astra-Zeneca Platelet aggregatioon inhibitor
PRODUCT NAME PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
CARDIOVASCULAR SYSTEM
18.Amlodipine (besilate) + Atorvastatin (calcium)
Film-coated tablets
5 mg + 10 mg | 10 mg + 10 mg | 10 mg + 20 mg | 5 mg + 20 mg
Norvasc (Amlodipine) +Sortis (Atorvastatin)/Pfizer
Calcium-channel blocker & cholesterol & triglyceride regulator combination
19. Amlodipine (maleate) + Valsartan Film-coated tablets
5 mg + 80 mg | 5 mg + 160 mg | 10 mg + 160 mg
Exforge/NovartisCalcium-channel blocker & angiotensin-II antagonist combination
20.
Amlodipine (maleate) + Valsartan + Hydrochlorothiazide* NEW!
Film-coated tablets
10 mg + 160 mg + 12.5 mg | 10 mg + 160 mg + 25 mg | 10 mg + 320 mg + 25 mg | 5 mg + 160 mg + 12.5 mg |
Exforge HCT/Novartis
Calcium-channel blocker & anigiotensin-II antagonist & diuretic combination
21. Bosentan * Film-coated tablets 62.5 mg | 125 mg Tracleer/Actelion Pulmonary arterial hypertension (PAH) treatment
22. Hydrochlorothiazide * Tablets 12.5 mg | 25 mg Esidrex/Novartis Diuretic
23. Indapamide Prolonged-release tablets 1.5 mg Natrilix/Servier Diuretic
24. Metoprolol succinate Prolonged-release tablets 23.75 mg | 47.5 mg | 95 mg | 190 mg
Beloc-Zoc/AstraZeneca Beta blocking agent
25. Metoprolol tartrate Solution for injection 1 mg/ml (5 ml) Betaloc/AstraZeneca Beta blocking agent
26. Noradrenaline (tartrate) (1) Solution for injection 1 mg/ml (1 ml, 4 ml) -- Vasopressor and cardiac arrest
management
27. Ramipril + Amlodipine (besilate) Capsules
5 mg + 5 mg | 5 mg + 10 mg | 10 mg + 5 mg | 10 mg + 10 mg
Tritace (Ramipril)/ Sanofi Aventis + Norvasc (Amlodipine)/Pfizer
Calcium-channel blocker & ACE inhibitor combination
28. Rosuvastatin (calcium) * Film-coated tablets 5 mg | 10 mg | 20 mg | 40 mg Crestor/AstraZeneca
Cholesterol & triglyceride regulator
29. Sildenafil (citrate) * Film-coated tablets 20 mg Revatio/Pfizer Pulmonary arterial hypertension (PAH) treatment
DERMATOLOGICALS
30. Dimetindene Gel 1 mg/g (20g, 30g, 50g) Fenistil/Novartis Topical antipruritic
GENITO-URINARY SYSTEM & SEX HORMONES
31. Tadalafil * Film-coated tablets 2.5 mg | 5 mg | 10 mg | 20 mg Cialis/Eli Lilly Erectile dysfunction treatment
32. Vardenafil (hydrochloride) * Film-coated tablets 5 mg | 10 mg | 20 mg Levitra/Bayer Erectile dysfunction treatment
AVAILABLE DOSSIERS
PRODUCT NAME PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS
CMYCMMY
CYCMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
MUSCULO-SKELETAL SYSTEM
33. Ibuprofen OTC Oral suspension 100 mg/ 5 ml (orange, raspberry , strawberry flavours) -- Non-steroid antiinflamatory
and antirheumatic
34. Ibuprofen OTC Oral suspension 200 mg/ 5 ml (raspberry, strawberry flavours) -- Non-steroid antiinflamatory
and antirheumatic
NERVOUS SYSTEM
35. Atomoxetine (hydrochloride) Capsules 5 mg | 10 mg | 18 mg | 25 mg |
40 mg | 60 mg | 80 mg | 100 mg Strattera/Eli Lilly ADHD treatment
36. Citalopram (hydrobromide) Film-coated tablets 10 mg | 20 mg | 30 mg | 40 mg Seropram/
Lundbeck Antidepressant
37. Haloperidol Solution for injection 5 mg/ml (1 ml) Haldol/Janssen Antipsychotic
38. Memantine hydrochloride Film-coated tablets 10 mg | 20 mg Ebixa/Lundbeck Alzheimer disease treatment
39. Propofol (1) Emulsion for injection or infusion 10 mg/ml (20 ml) Diprivan/
AstraZeneca Anaesthetic
40. Quetiapine (fumarate) Film-coated tablets 25 mg | 100 mg | 150 mg | 200 mg | 300 mg
Seroquel/AstraZeneca Antipsychotic
OPHTHALMOLOGICALS
41. Bimatoprost Eye drops solution without preservatives 0.3 mg/ml (3 ml) Lumigan/
Allergan Miotic & antiglaucoma
42. Bimatoprost + Timolol (maleate)
Eye drops solution without preservatives (0.3 mg + 5.0 mg) /ml (3 ml) Ganfort/Allergan Miotic & antiglaucoma
43. Dorzolamide (hydrochloride)
Eye drops solution without preservatives 20 mg/ml (5 ml) Trusopt/MSD Miotic & antiglaucoma
44.Dorzolamide (hydrochloride)+ Timolol (maleate)
Eye drops solution without preservatives (20 mg + 5 mg)/ml (5 ml) Cosopt/MSD Miotic & antiglaucoma
RESPIRATORY SYSTEM
45. Hedera helix dry extract OTC Syrup 27,78 mg/5 ml (100 ml) -- Expectorant
46.Xylometazoline (hydrochloride) + Dexpanthenol (2) OTC
Nasal spray solution (1 mg + 50 mg)/ml (10 ml) Nasic/Cassella-med
Nasal descongestant & mucosal regenerator
* Polpharma Group API** Polpharma Group API + US dossier available(1) Dossier update not earlier than Q3 2019(2) Dossier availability subject to some restrictions Herbal medicinal product
For more information and up-dates regarding available dossiers and dossiers in development, please contact your assigned Sales Manager or our Commercial Department. Note: Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. Availability may be restricted to certain markets or countries.
PRODUCT NAME PHARMACEUTICAL FORM STRENGTH REFERENCE THERAPEUTIC CLASS
March 2018
C
M
Y
CM
MY
CY
CMY
K
tlo_SELEDYN.pdf 1 22.08.2017 14:38:01
WE OFFER
High level of customer service
Excellent products with CTD dossiers meeting EU requirements
Regulatory knowledge and expertise
Full support in developing registration strategies to meet the needs of our customers
Execution and support in registration procedures upon customer’s request
QA service and pharmacovigilance service (PSUR)
Intellectual property expertise
Highly skilled and professional team of Project Managers
Partnership in a win-win strategy
C M Y CM MY
CY CMY
K
tlo_S
ELED
YN.p
df
1 2
2.08
.201
7 1
4:38
:01
C M Y CM MY
CY CMY
K
tlo_S
ELED
YN.p
df
1 2
2.08
.201
7 1
4:38
:01
CONTACT
POLPHARMA GROUPPHARMACEUTICAL WORKSPelplińska 1983-200 Starogard GdańskiPolandPhone: +48 58 563 16 00Fax: +48 58 562 23 53www.polpharma.pl
POLPHARMA B2BSTRATEGIC PARTNER, FARMAPROJECTSCarrer Provença 392, 6ª Planta 08025 Barcelona (Spain)Phone: +34 93 508 05 00Fax: +34 93 508 05 01e-mail: [email protected]
Meet us on LinkedIn:
www.linkedin.com/company/polpharma-b2b
