The Hyderabad-based Granules India and Amneal Pharmaceuticals LLC (United States) have obtained an approval of the ANDA of Metformin Hydrochloride tablets of 500 mg, 850 mg and 1000 mg. This is the first time that the FDA has approved an ANDA with a PFI (Pharmaceutical Formulation Intermediate)- 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 driven by economies of scale, on supply chain management of API and excipients being the largest manufacturer of these mixes.
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 United States. We are glad to be associated with a reliable partner like Granules India for the raw material supply."
Krishna Prasad, managing director, Granules India, 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."
Granules is a fully integrated pharmaceutical formulations manufacturer with the world's largest 'granulation' capacity. The company manufactures several strategic Active Pharmaceutical Ingredients (APIs) and multiple Pharmaceutical Formulation Intermediates (PFIs), which are distributed in 35 countries.