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Corporate - Regulatory Bodies & Rulings


Orchid gets USFDA nod for Cefoxitin

Our Bureau

Chennai , Jan. 28

ORCHID Chemicals & Pharmaceuticals Ltd said it has received the formal approval from the USFDA for its ANDA (Abbreviated New Drug Application) for Cefoxitin for injection, 1 gm/vial and 2gm/vial.

Cefoxitin is the generic version of Merck's Mefoxin. Orchid is launching this product in the US exclusively through Apotex.

A company spokesman told Business Line that the size of the "genericised" market is $38 million.

The other player in the business is American Pharmaceutical Partners, Inc.

In a press release, Orchid's Managing Director, Mr K. Raghavendra Rao, has observed that Orchid was the second generic company to enter the market and "hence we expect a good market share and revenues."

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