Company Watch

Granules India gets FDA nod

Our News Bureau - Mumbai

Granules India and Amneal Pharmaceutical (United States) announced the approval of its ANDA of Metformin Hydrochloride tablets of 500 milligram, 850 milligram and 1000 milligram. This is the first time that USFDA has approved an ANDA with a Pharmaceutical Formulation Intermediate (PFI)—DMF as a raw material.

The PFI concept of Granules India 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 USFDA has 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 model.

Commenting on the development, Chintu Patel, CEO and President, Amneal Pharmaceuticals said, "This is a major milestone in our development as a key player in the pharmaceutical markets of the US. We are glad to be associated with Granules India for the raw material supply.

The PFI concept of Granules India was unique and truly the next level in pharmaceutical supply chain outsourcing model." Krishna Prasad, Managing Director, Granules India said, "We always wanted to improvise on our outsourcing offerings and this has provided us with a strong opportunity to do so. The recognition by USFDA, 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."