Granules India to launch metformin 1000mg generic pills in US

Granules India has received US FDA approval for metformin 500mg, 850mg and 1000mg.

Granules has filed the abbreviated new drug application (ANDA) in collaboration with Heritage Pharmaceuticals Inc.

Heritage retains exclusive sales and marketing rights to the meformin ANDA for several years. Both parties will share net profits from product sales.

“Receiving approval for our first ANDA is an exciting step in our effort of becoming a leading formulation manufacturer,” stated C Krishna Prasad, managing director at Granules India.

Granules will continue to focus on filing more ANDAs in the future in order to better target the lucrative US market, he added.

Granules India Ltd is a manufacturer of finished dosages (FDs), pharmaceutical formulation intermediates (PFIs) and active pharmaceutical ingredients (APIs), which are distributed in over 50 countries.

Granules has a long history as a producer of active pharmaceutical ingredients (APIs) and pharmaceutical formulation intermediates (PFIs) and recently expanded into finished dosages (FDs) through our state-of-the-art facility at Gagillapur. We support customers with unique value, extensive product range and a global network of associates.

Granules is a fully vertically integrated pharmaceutical manufacturing company with three core lines: Active Pharmaceutical Ingredients (APIs) – Granules has 3 factories manufacturing APIs.

Granule is among the top global manufacturers of paracetamol and ibuprofen.

Granules pioneered the concept of pharmaceutical formulation intermediates (PFIs) –and currently has 2 factories manufacturing single and multiple – active PFIs.

Granules recently opened a dedicated formulations plant at Gagillapur facility. The plant has the capacity to produce 6 billion tablets annually and is scalable up to 12 billion tablets. The facility has received approval from Infarmed and the Australian TGA.

Granules has a presence in three major European markets – Germany, England and France. In the past few years, the main drive of the company’s growth in this market has been its API & PFI business. With the increase in the formulations business opportunities in Europe, Granule’s main focus now will be on the finished formulation contacts with the large pharmaceutical companies.

Granules USA Inc. is a 100 percent owned U.S.-based subsidiary that provides existing and prospective customers in U.S. with a direct interface. With FDA and TGA approved manufacturing facilities, we have had a solid platform for growth in this key region.

Granules operations in the United States are conducted through its fully owned subsidiary – Granules USA Inc,