Strides Arcolab's subsidiary Onco Therapies has received US FDA approval for topotecan hydrochloride injection 4 mg (base), packaged in single dose vials. Topotecan is a chemotherapy drug usually given to treat ovarian cancer, small-cell lung cancer and advanced cervical cancer. It is part of the oncology portfolio licensed to Pfizer for the US market and the product is available for immediate launch.
According to IMS data, the US market for generic topotecan is approximately US$ 51 million.
Strides Arcolab, a Rs. 2,500 crore pharma major has 14 manufacturing facilities across six 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. Its Agila, specialties business, is focused on key domains such as oncolytics, penems, pencillins, cephalospoorins, ophthalmics, peptides and biosimilars and operates from nine world-calss global manufacturing facilities.