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Strides Arcolab gets USFDA approval for cancer drug unit

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Drug firm Strides Arcolab today said it has received the US health regulator's approval for its oncology facility in Bangalore.

Onco Therapies Ltd, a division of Agila which is a wholly owned subsidiary of the company, has received US Food and Drug Administration (USFDA) approval for its oncology facility, Strides Arcolab said in a statement.

Commenting on the approval, Agila Specialties CEO Venkat Iyer said: "With this approval and the recently announced approval for the sterile complex, we now look forward to scaling up our specialty business through the launch of highly specialised products for the US market."

The company recently received USFDA approval for its sterile facility (non-oncology) in Bangalore. With these approvals, all of Strides' five sterile plants in India are now USFDA approved, it said.

Agila is the specialties unit of Strides Arcolab which was spun off into a separate division post the company's restructuring in 2009.

The Bangalore facility was established in 2009 and manufactures injectables, oral products (tablets and softgels) in the oncology domain.

"This approval is an important step in strengthening our specialty business and intent to be a global sterile powerhouse," Strides Arcolab Vice-Chairman & Group CEO Arun Kumar said.

USFDA approval for the new facility will give impetus to the company's collaborations with global pharma companies, including Pfizer and .

In January, 2010, the company had announced a licencing and supply collaboration with Pfizer Inc on 40 generic products for the US market.

The Bangalore-based firm said it expects to commercialise its first oncology product for the US market in the beginning of the second half of 2011.

Further, in May, 2010, the company extended its partnership with Pfizer Inc by extending the oncology agreement to Europe, Canada, Australia, New Zealand, Japan and Korea for 38 generic oncology products.

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