Strides Arcolab’s subsidiary gets US FDA approval for Gemcitabine

26 Jul 2011 Evaluate

Onco Therapies, a division of Agila, which is a wholly owned subsidiary of Strides Arcolab, has received United States Food and Drug Administration (US FDA) approval for Gemcitabine for Injection USP in 200mg, 1 gm and 2 gm dosage forms.

Gemcitabine is the first product to be approved from its Oncology facility at Bangalore, which was certified for compliance by US FDA in May 2011. According to March 2011 data, the US market for Gemcitabine is about $700 million. Gemcitabine is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market and will be launched immediately.

Strides are amongst the first wave players to receive this approval and amongst the few companies approved for all three dosage forms.

Earlier in this month, Onco Therapies received European approval for its Oral Dosage Oncology facility (tablet and hard gelatine capsules) in Bangalore. The injectable facility within the Oncology complex has already been approved by all major regulatory agencies.

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