Strides Arcolab’s Onco Therapies receives US FDA approval for Ifosfamide
Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited has received ANDA (Abbreviated New Drug Approval) for Ifosfamide injection 50 mg / mL packaged in one gram/20 mL and three gram/60 mL single-dose vials.
According to IMS data, the US market for generic Ifosfamide is approximately US$ 15 million.
Ifosfamide is part of the Oncology portfolio licensed to Pfizer for the US market and the product is available for immediate launch.
Ifosfamide is a chemotherapy drug that is usually used to treat sarcoma, testicular cancer and some types of lymphomas. Occasionally, it may be used to treat other types of cancer.
Agila, specialities business of Strides Arcolab, is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from nine 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 has 14 manufacturing facilities across six countries with presence in more than 75 countries in developed and emerging markets. There are 350 scientists working out of its global R&D Centre located in Bengaluru.