Onco Therapies Ltd, a wholly owned subsidiary of Strides Arcolab Ltd, has announced that it has received USFDA approval for Gemcitabine for Injection USP in 200mg, 1 gm and 2 gm dosage forms.
The company in a release said Strides is amongst the few companies approved for all three dosage forms. Gemcitabine is the first product to be approved from its oncology facility at Bangalore, which was certified for compliance by USFDA in May. The US market for Gemcitabine is estimated to be $700 million.
Gemcitabine is part of the oncology portfolio licensed to Pfizer in January 2010 for the US market and is to be launched immediately.
Commenting on the development, Mr Venkat Iyer, Executive Director, Strides Arcolab and CEO, Agila Specialties, said, “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.”
He further stated that the oncology approval flow is expected to gain momentum in the coming days.