FDAnews
www.fdanews.com/articles/61418-granules-india-receives-1st-fda-approval-for-anda-with-pfi

GRANULES INDIA RECEIVES 1ST FDA APPROVAL FOR ANDA WITH PFI

August 3, 2006

Granules India Ltd. and Amneal Pharmaceuticals LLC (United States) are pleased to announce the approval of the ANDA of Metformin Hydrochloride tablets of 500 mg, 850 mg and 1000 mg. This is the first time that the FDA has approved an ANDA with a PFI (Pharmaceutical Formulation Intermediate) -- DMF as a raw material.

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