Granules, Amneal Pharma get FDA nod

Granules India Limited and Amneal Pharmaceuticals LLC of the United States have received the approval for their abbreviated new drug application (ANDA) of Metformin Hydrochloride tablets of 500 mg, 850 mg and 1000 mg.

This is the first time that the USFDA has approved an ANDA with a PFI (pharmaceutical formulation intermediate)-drug master file ( DMF) as a raw material, the companies claimed in a press release here on Tuesday.

The PFI concept of Granules India involves preparing a 'ready-to-compress' mix of active pharmaceutical ingredients and excipients which can then be directly fed into a hopper for compression of tablets.

"This development has helped us being recognised as more than an over-the-counter player and has opened up a new vista of business opportunities for Granules India," the company's managing director, Krishna Prasad, stated.