Pharmabiz
 

Strides gets European approval for oxaliplatin injection

Our Bureau, MumbaiThursday, September 15, 2011, 14:55 Hrs  [IST]

Onco Therapies Limited (OTL), the wholly owned oncology (cancer drugs) subsidiary of Strides, announced European Union (EU) approval for oxaliplatin injection 5 mg/ml (10 ml, 20 ml and 40 ml). This is the second European approval out of the 22 filings made by OTL in the year 2010 for products which have a combined market value of over US$ 5 billion. The application for oxaliplatin 5 mg/ml was submitted through a Decentralized Procedure (DCP).

The current approval is from UK and approval for the rest of the European countries is expected shortly.

The product will be manufactured at the oncology complex in Bangalore.

Oxaliplatin 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 oxaliplatin stood at US$ 312 million with 4 major players in the market.

Oxaliplatin is a chemotherapy drug used to treat advanced cancer of the colon and rectum. It is used in combination with other medications to slow or stop cancer cell growth.

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 8 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.

Strides Arcolab, a global pharmaceutical company that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.

 
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