Granules, Amneal get FDA OK for generic metformin

By Elaine Rigoli

Tampa, Fla., Aug. 1 - Granules India, Ltd. and Amneal Pharmaceuticals, LLC said Tuesday that the companies' abbreviated New Drug Application for metformin hydrochloride tablets 500 mg, 850 mg and 1,000 mg has been approved.

The FDA approved this abbreviated NDA within 11 months of filing, according to a news release.

"We always wanted to improvise on our outsourcing offerings and this has provided us with a strong opportunity to do so. The recognition by FDA, through this approval, has proven our capabilities to handle commercial granulations of any product, a know-how that has been developed by us over the last 10 years of operations," Granules managing director Krishna Prasad said the release.

Amneal manufactures and markets pharmaceutical products and is based in Paterson, N.J.

Granules is a pharmaceutical company based in Hyderabad, India.

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