Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited has received US FDA approval for carboplatin injection 10 mg/ mL packaged in 50 mg/ mL, 150 mg/ 15 mL, 450 mg/ 45 mL and 600 mg/ 60 mL multi-dose vials. The drug is marketed by Agila which is the specialties unit of Strides Arcolab which was spun off as a separate division post the company’s restructuring in 2009.
According to IMS data June’11, the US market for generic carboplatin is approximately US$ 35 million.
Carboplatin is part of the oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly. This 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.
Agila Specialties 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.
Strides Arcolab, develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables. The company has 14 manufacturing facilities across 6 countries with presence in more than 75countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.