Mumbai: Drug maker Ranbaxy’s wholly-owned US subsidiary has received USFDA (US Food and Drugs Administration) approval to market Metformin Hydrochloride tablets, used for treating diabetes.
Ohm Laboratories, set up under the strategic alliance between Ipca Laboratories and Ranbaxy Pharmaceuticals, has got the sanction from USFDA, Ipca Laboratories said in a filing to the Bombay Stock Exchange on 13 August.
Florida-based Ranbaxy Pharmaceuticals is also a 100% subsidiary of Ranbaxy Laboratories.
The approval was given for Metformin Hydrochloride USP tablets in multiple strengths of 500 mg, 850 mg and 1,000 mg in the US market, Ipca said.
Total annual market sales for Metformin HCL tablets in the US stands at $379 million , according to IMS-MAT March 2007 data.
Ipca Laboratories would manufacture this formulation in its facilities in India and is setting up a new manufacturing unit, meeting the US regulatory requirements, in Indore.
Ranbaxy would commercialise this product in the US market through its established marketing expertise and distribution network.