Onco Therapies Limited (OTL), the wholly owned oncology (cancer drugs) subsidiary of Strides, announced European Union (EU) approval for Carboplatin 10 mg/ ml in the first wave covering select European countries. This is the first European approval out of the 22 filings made by OTL in the year 2010 for products which have a combined market value of over USD 5 billion. The application for Carboplatin 10 mg/ml was submitted through a Decentralized Procedure (DCP). The second wave of filing for Carboplatin will commence immediately to cover all the remaining EU countries. Approval for all countries is expected during 2011.
The product will be manufactured at Strides’ Oncology complex in Bangalore which received approval from the European regulatory authorities in June, 2010.
Carboplatin is amongst 37 drugs licensed to Pfizer on a semi-exclusive basis for sales in 17 European countries.
As per the latest data available from IMS, the combined European market for Carboplatin stood at USD 138million.
About Carboplatin
Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents, and in secondary treatment of advanced ovarian carcinoma which has recurred after prior chemotherapy.
About Agila Specialties
Agila Specialties Private Limited is the specialties unit of Strides Arcolab which was spun off as a separate division post the Company’s restructuring in 2009. It is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from 7 world class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world. Agila’s marketing network covers 70 countries and it has partnerships with some of the world’s leading pharmaceutical companies for both developed and emerging markets.
About Strides Arcolab Limited
Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.
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The company has 14 manufacturing facilities across 6 countries with presence in more than 75 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.
Additional information is available at the company’s website at www.stridesarco.com.