USFDA nod for Granules India drug

Hyderabad, Aug 1 (UNI) Granules India Ltd and Amneal Pharmaceuticals LLC (US) have obtained USFDA approval for ANDA of metformin hydrochloride tablets in 500 mg, 850 mg and 1,000 mg dosages.

Granules India Managing Director Krishna Prasad claimed in a statement here today this was the first time the USFDA had approved an ANDA with a Pharmaceutical Formulation Intermediate (PFI)-DMF as a raw material.

He said this development had helped them being recognised as more than an OTC player and opened up new vistas of granule business.

Through the USFDA approval, the company had proved its capability to handle commercial granulations of any product.

The Amneal Pharmaceuticals said this was a major milestone in their role as a key player in the pharmaceutical market of the United States.

UNI BR JJ GM 2014