Ipca-Ranbaxy JV gets USFDA approval
New Delhi, Aug 13: Ipca Laboratories today said its joint venture(JV) with Ranbaxy Laboratories has received the US Food and Drug Administration's (USFDA) approval to sell Metformin HCL tablets.
Under the alliance, Ohm Laboratories Inc (Ohm), wholly-owned subsidiary of Ranbaxy Laboratories Ltd (RLL), will manufacture and market Metformin Hydrochloride tablets 500mg, 850mg and 1000mg in the US market.
Total annual market sales for Metformin HCL tablets in the US is 379 million dollars, company said in a statement.
This is the fifth such product approval received under the alliance from USFDA.
The company will manufacture this formulation from its facilities in India. It is also setting up a new formulations manufacturing unit, meeting US regulatory requirements at SEZ Indore.
UNI