Avra Laboratories Pvt. Ltd.

Transcription

1 Avra Laboratories Pvt. Ltd.

2 Company Overview Introduction Avra Laboratories Private Limited is amongst the first companies in India to focus on Providing high-end contract research Custom synthesis of complex chemicals Manufacturing of niche intermediates and APIs covering various therapeutic areas including oncology Its subsidiary Avra Synthesis Private Limited is engaged in providing high quality, pre-tested laboratory chemicals and reagents to various research organizations, companies and academic institutions Has 4 R&D and manufacturing facilities (including one facility owned by Avra Synthesis) located in Hyderabad and Visakhapatnam in India Facilities are certified with ISO 9001 and the company follows cglp and cgmp practices USFDA approved facility The company has been profitable since its first year of operations Avra s vision is to become a global research organization with core competencies in chemistry and to be recognized as a reliable long term partner by global pharmaceutical companies

3 Company Overview The journey so far Unit-2 FDA approval Started production- Vizag plant 2007 Constructed Oncology facility 2005 Started Avra Synthesis 2002 Production began at unit 2, Nacharam, Hyderabad 2000 Acquired manufacturing facilities of Uniloids Limited (now unit 2) 1997 Started production at Unit 1, Nacharam, Hyderabad 1995 Commenced business in a temporary facility provided by Dai-ichi Karkaria at Hyderabad Avra Laboratories was founded by eminent scientist Dr. A V Rama Rao

4 Products and Services Overview Avra s aim is to become a one-step destination for international pharmaceutical companies that require chemistry based support starting from lead generation till commercial production of APIs and intermediates Contract research and custom synthesis Collaborative research Innovative research and organic chemistry capabilities Process chemistry and contract manufacturing Specialty fine chemical synthesis Specialty and niche generics

5 Products and Services Specialty and Niche Generics Specialty and niche generics Currently focuses on cytotoxic drug class in cancer treatment World s first company to develop a synthetic route for manufacturing camptothecin derivatives including Irinotecan (trade name Camptosar) and Topotecan (trade name Hycamtin) Various molecules in pipeline First company in the world to develop a synthetic route for manufacturing of camptothecin derivatives like Irinotecan and Topotecan, which provides for significantly higher levels of drug purity compared to the existing product forms Irinotecan is used in combination therapy for treatment of colon cancer and Topotecan is used in the treatment of various cancers like ovarian, lung etc. Supplies Irinotecan intermediates to various pharma companies in India and abroad Various pharma players are planning to file DMFs based on Avra s Intermediates Irinotecan Hydrochloride Topotecan Hydrochloride 7-Ethyl-10-hydroxycamptothecin (SN-38) 10-hydroxycamptothecin

6 Products and Services Products commercial R&D development Misoprostol 1% HPMC Irinotecan Hydrochloride Lenalidomide 7-Ethyl-10-hydroxycamptothecin 10- hydroxycamptothecin Topotecan Hydrochloride Travoprost Abiraterone acetate Ticagrelor Eltrombopag % HPMC % HPMC

7 Manufacturing and R&D Infrastructure Overview Avra Group Unit 1, Hyderabad Unit 2, Hyderabad Unit 3, Hyderabad Vizag Unit Total area 2 acres Corey and Venkatraman research wings Pilot plants Total area 6 acres Fleming and Ley research block Pilot plants Sune Bergstrom cgmp manufacturing facility USFDA approved facility Total area 2.5 acres Owned by Avra Synthesis Engaged in selling lab chemicals Total area 20.4 acres Large scale manufacturing of APIs About 10 acres of land is being developed To comply with international research and manufacturing standards, Avra has implemented comprehensive documentation for standard operating procedures, test method documentation, limit specifications and qualifications The R&D labs are ISO 9001 certified and cglp complaint Manufacturing facilities are cgmp compliant

8 Human Resource Overview Department wise employees* Total employees % 32% 12% 15% 23% Production HR, admin & finance Others** R&D QA / QC * Total employees are as on April 2014, including 100+ employees on contractual basis * Total employees are only for Avra Labs; Avra Synthesis employs ~ 35 people ** Others include electrical, excise, maintenance, supply chain

9 Thank you Plot No. A-21, Road No.10, IDA Nacharam, Hyderabad , Andhra Pradesh, India Tel: Fax: Mobile : Web: