Ipca Laboratories Ltd and Ranbaxy Pharmaceuticals Inc. (Ranbaxy) based in Jacksonville, Florida (USA), a wholly owned subsidiary of Ranbaxy Laboratories Ltd. (RLL), India's largest pharmaceutical company, have made a strategic alliance for manufacturing and marketing Metformin HCL tablets in the US.
Under the strategic alliance, Ohm Laboratories Inc. (Ohm), wholly owned subsidiary of RLL has now received approval from US Food and Drugs Administration to manufacture and market metformin hydrochloride USP tablets 500mg, 850mg and 1000mg in the US market. Total annual market sales for metformin HCL tablets in US were US$ 379 millions. This is the fifth such product approval received under the alliance from US FDA.
The company will manufacture this formulation utilizing its facilities in India. The company is setting up a new formulation manufacturing facility meeting US regulatory requirements at SEZ Indore. The company is already holding US DMF of metformin HCL.
Ranbaxy will commercialise this product in the US market utilizing its established marketing expertise and distribution network.