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Thursday, Jun 30, 2005

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Orchid gets ANDA approval for oral drug

Our Bureau

CHENNAI: Orchid Chemicals and Pharmaceuticals on Wednesday announced that it has received approval from the USFDA for its ANDA (Abbreviated New Drug Application) of Cephalexin capsules USP 250 mg and 500 mg.

"This is the first ANDA approval received by the company in the oral formulations segment in the US," says a press release from the company.

Cephalexin is an off-patent molecule that forms part of Orchid's distribution alliance with US generic pharma major Par Pharmaceuticals Inc.

"Orchid earlier received ANDA approval from the USFDA for its sterile injectable generic product Cefazolin. Orchid expects to receive further USFDA approvals based on the review of ANDAs currently under way," the release says.

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