Granules India gets first FDA approval for an ANDA with a PFI

Mumbai, Aug 1 (UNI) Granules India and Amneal Pharmaceuticals LLC (United States) has announce the approval of the ANDA (abbreviated new drug application) of Metformin Hydrochloride tablets of 500 mg, 850 mg and 1000 mg.

Informing the BSE, Granules India said this is the first time that the FDA has approved an ANDA with a PFI (Pharmaceutical Formulation Intermediate) - DMF(dimethylformamide) as a raw material.

The PFI concept of the Company involves preparing a ''ready to compress'' mix of APIs and Excipients which can then be directly fed into a hopper for compression of tablets. This unique concept relies on generating a business model that is driven by economies of scale, on supply chain management of API and Excipients being the largest manufacturer of these mixes.

The fact that the FDA have approved this ANDA within 11 months of filing has shown the way for a greater reach for Granulated products in this arena, thereby strongly reinforcing the business model of the Company.

Mr Krishna Prasad, Managing Director, of the Company, was very upbeat about the development and said, ''This development has helped us being recognised as more than an OTC player and has opened up a new vista of business opportunities for Granules. We always wanted to improvise on our outsourcing offerings and this has provided us with a strong opportunity to do so. The recognition by FDA, through this approval, has proven our capabilities to handle commercial granulations of any product, a know-how that has been developed by us over the last ten years of operations.'' UNI SN MAZ SKB2058