A.R. Life Sciences Group

CORPORATE PROFILE

Index

� Brief Profile

�Operating Verticals

� Infrastructure

� Products – API’s

� Research & Development

� Quality Systems/ GMP Certifications

� Regulatory Affairs

� Pollution Control Health and Safety Standards

A.R. Life Group

A.R. LIFE SCIENCES (ARLS) – Brief Profile

� Evolution of A R Life - 1996.

� LeadershipMr. Kallam Subba Reddy, Managing Director ,Strong legacy working with Dr. Reddy’s for over

20 years

Mr. Krishna Chaitanya, Executive Director Marketing & Operations. From India's premier institute - IIT Roorkee

� Product Verticals - Intermediates & APIs

� Acquired Dymes Pharmachem Ltd (Dymes) in 2014

� Global Network

� Total employees: 100 to 120

� Aim – GLOBAL LEADER IN Intermediates and APIs

A.R. Life Group

PRODUCT VERTICALS

APIs: Current Portfolio : 2

Under Development: 3

INTERMEDIATES:Current Portfolio : 27 Intermediates

Under Development : 12 Intermediates

COSMETICS & PRESERVATIVESCosmetics Ingredients : 10Preservative under development: 1

Pharmaceutical IntermediatesActive Pharmaceutical Ingredients

Key Business Segments

A.R. Life Group

ARLS - Infrastructure Intermediates Manufacturing Facility with Multi product

manufacturing capabilities.Operations

� Total Plant Area : 4047 Sq Mts

� Total No of Reactors : 20 (15 SSR & 5 GLR)� Reaction Volume with Concurrent scaling-up and Piloting: Over 35

KL

� Complete Onsite QA/QC/RA/R&D Support

� No of Employees : 60

� Dedicated block to carry out high pressure reactionsQuality Control:

Dedicated Analytical and Wet Lab with the following Major Analytical

Equipment� HPLC – 3 Nos

� GC – 2 Nos

� Potentiometer – 1 Nos� Others – KF Titrator, Melting range

apparatus, UV chamber, pH meter, Ovens, muffle furnace, etc.,

A.R. Life Group

Dymes - Infrastructure Operations

� Total Plant Area : 5466 Sq Mts

� Total No of Reactors : 25� Reaction Volume with Concurrent scaling-up and Piloting

:50KL

� No of production blocks : 2� Pharma area : 2 clean room

� Complete Onsite QA/QC/RA/R&D Support

� No of Employees : 65One dedicated block to carry out high pressure reactions (upto40 kg), cryogenic reactions (upto -80 Deg C) available

Quality Control:

� Dedicated Analytical and Wet Lab with the following Major Analytical Equipment

� HPLC – 3 Nos (Including one with RI

detector)

� GC – 2 Nos� IR – 1 Nos� Others – KF Titrator, Melting range

apparatus, UV chamber, pH meter, Ovens, muffle furnace, weighing balances, etc A.R. Life Group

Intermediates Product ListHigh Quality intermediates for following APIs

Commercialised :

� Ondansetron� Racecadotril

� Dabigatran

� Ibandronate Sodium� Zoledronic acid

� Mirabegron

� Clopidogrel bi sulphate� Sitagliptin

� Dabigatran

Developed in lab to be commercialized:

� Quetiapine Fumarate

� Tenofovir� Bendamustine

� Dasatinib

A.R. Life Group

API Product List*

GENERIC NAME CAS NO SPECIFICATION THERAPEUTIC USAGE STATUS

Clopidogrel bi sulphate 120202-66-6 USP Cardiovascular Commercial

Sitagliptin phosphate 654671-77-9 In-house Anti-Diabetic Lab Scale

Dabigatran Etexilate

Mesylate872728-81-9 In-house Anti-Coagulant

Under

Development

Quetiapine fumarate 111974-72-2 IP / USP Anti-psychoticUnder

Development

Rosuvastatin Calcium 147098-20-2 IP Anti-lip emicUnder

Development

A.R. Life Group

Research & Development

Fully Integrated & Qualified R&D Team of 12 Scientists

Key Functions� Identification and Development� Characterization and Synthesizing of Impurities� Analytical methods developments

Key Initiatives of On site R&D team � Cost Reduction & Quality Improvement� Technology Transfer from R&D to Plant (Scale up &

Validations)� Troubleshooting� Customer support

A.R. Life Group

DYMES - PHOTOS

A.R. Life Group

DYMES -PHOTOS

A.R. Life Group

CLEAN ROOM -PHOTOS

A.R. Life Group

ARLS -PHOTOS

A.R. Life Group

Reaction Capabilities

� Grignard reactions

� Hydrogenation

� Alkylation reactions

� Halogenations reactions.

� Oxidation reactions

� Reduction reactions

� Esterification reactions

� Hydrolysis reactions

� Condensation reactions

� De-hydrogination reactions.

� Allylic bromination reactions

� Cyclization reactions

A.R. Life Group

Regulatory Affairs

� Regulatory system in place for preparation and filing of DMF, CEP, CTD, etc

� Open part DMF level documentation support for intermediates also

A.R. Life Group

Quality Systems

� Both Plants meet International Standards

� World Class Quality Assurance team Complying to GMP guidelines

� ISO Certification for both units and GMP &WHO GMP certification for Dymes plant

� Quality control department equipped with instruments like HPLC, and GC

� Extensive SOPs including � Change control� Equipment qualification and calibration � Process validation� Deviation handling� Customer complaint handling

� GMP trainings conducted from time to time

A.R. Life Group

GMP Certifications / Compliance

� ISO 9001 -2008 Certified

� WHO GMP certificate (India)

� Approved Vendor for Various Major Pharmaceutical companies World Wide including Dr Reddy’s Laboratories Ltd, Teva API, Moehs, Cipla, Torrent, Cadila,etc.,

A.R. Life Group

Pollution Control, Health and safety

StandardsPollution Control

� Fully Integrated ETF plant ensures zero discharge� Solid waste sent to State approved disposal facility� Scrubbing systems in place to ensure acidic vapours do not

go into atmosphere

Health

� Nose Masks, hand gloves and goggles worn� Regular health check-up � Regular Trainings session on care to be taken in chemical

plant

Safety

� PPE for all employees including casual labour� Earthing wherever there is a possibility of static electricity � Safety trainings (Education on static electricity and its

avoidance, use of fire extinguishers, Mock drills, etc.,) conducted from time to time

A.R. Life Group

THANK YOU

Registered Office:

H.No. 8-3-222/1/5, Behind Allahabad Bank, Madhuranagar, Yousufguda Road,

Hyderabad - 500 038.

(Email: info@arlifesciences.com)

Sites Address 1: Sites Address 2:

A R Life Sciences Pvt Ltd: Dymes Pharmachem Ltd:

Plot No. 338, Plot No. 33,

S.V. Co-operative Industrial Estate, S.V. Co-operative Jeedimetla,

Hyderabad - 500 055. Jeedimetla, Hyderabad - 500 055.

Telangana. India Telangana, India.

A.R. Life Group