Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited has bagged the US FDA approval for doxorubicin hydrochloride injection, 10 mg/ vial and 50 mg/ vial. 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.
Doxorubicin is amongst the products in the drug shortage list of US FDA. According to IMS data June’11, the US market for generic doxorubicin (Liquid and Lyophilized) is approximately US$ 16.8 million.
Agila 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. Its marketing network covers 70 countries and it has partnerships with some of the world’s leading pharmaceutical companies for both developed and emerging markets which include GSK and Pfizer.
Doxorubicin is part of the oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly. It is a chemotherapy drug, commonly used in the treatment of a wide range of cancers, including haematological malignancies, many types of carcinoma, and soft tissue sarcomas. The drug is administered intravenously, in the form of hydrochloride salt.