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Granules' product gets USFDA nod

HYDERABAD: Granules India and Amneal Pharmaceuticals LLC of the U.S. have announced that their metforimn hydrochloride tablets of 500 mg, 850 mg and 1,000 mg secured the abbreviated new drug application (ANDA) approval from the U.S. Food and Drugs Administration. This is the first time the USFDA had approved an ANDA with PFI (pharmaceutical formulation intermediate) with DMF as raw material.

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