Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited has received US FDA approval for Gemcitabine for injection USP in 200mg, 1 gm and 2 gm dosage forms. The drug is the first product to be approved from its oncology facility at Bangalore, which was certified for compliance by US FDA in May 2011. It is also part of the oncology portfolio licensed to Pfizer in January 2010 for the US market and will be launched immediately.
Strides is amongst the first wave players to receive this approval and amongst the few companies approved for all three dosage forms. According to March 2011 data, the US market for Gemcitabine is around US$ 700 million.
“We are delighted with this milestone approval marking our foray into the US oncology market. Commercialisation of this product will further strengthen the Pfizer – Strides partnership in the global oncology space” said Venkat Iyer, executive director, Strides Arcolab and CEO, Agila Specialties.
He further stated that the oncology approval flow is expected to gain momentum in the coming days. Gemcitabine for injection USP, the generic form of the chemotherapy drug Gemzar is a nucleoside metabolite inhibitor that exhibits anti-tumour activity. It is available as a lyophilised powder for injection indicated for ovarian cancer, breast cancer & non-small cell lung cancer in combination with other drugs and in treatment of pancreatic cancer as a single-agent.
Agila 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, penicillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from eight 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.