ANDA approves Granules India, Amneal

Hyderabad, Aug 1 (UNI) Granules India Ltd and Amneal Pharmaceuticals LLC (US) have obtained the approval of the ANDA of Metformin Hydrochloride Tablets of 500 mg 8750 mg and 1,000 mg.

The Pharmaceutical Formulation Intermediate (PFI) concept of Granules India involves preparing a 'ready to compress' mix of APIs and Excipients which could then be directly fed into a hopper for compression of tablets.

'Granules India' Managing Director Krishna Prasad said in a statement today that this was the first time that the FDA had approved an ANDA with a PFI- DMF as a raw material.

He said this development had helped them being recognised as more than an OTC player and had opened up a new vista of business opportunities for Granules.

The recognition by FDA through this approval had proved their capabilities to handle commerical granulations of any product, a know-how that was developed by them over a decade-old operations.

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

UNI BR JJ 1837