Ranbaxy Laboratories’ wholly owned subsidiary - Ohm Laboratories, Inc. (Ohm), has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Valsartan 40 mg, 80 mg, 160 mg, and 320 mg tablets on an exclusive basis. Valsartan is indicated for the treatment of high blood pressure and heart failure.
USFDA has determined the Ohm formulations to be bioequivalent and have the same therapeutic effect as that of the branded drug Diovan. The total annual market sales for Diovan were $2.19 billion, according to IMS-MAT: April 2014.
Ohm was the first-to-file FDA approval for Valsartan tablets, which will be introduced to all classes of trade, with 180-days marketing exclusivity, as soon as sufficient supplies are manufactured to meet the needs of the market. Valsartan will be manufactured at the Ohm facilities located in New Brunswick, New Jersey.
Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories, India’s largest pharmaceutical company. Ohm is engaged in the manufacturing, sale and distribution of generic and branded private label, (OTC) products in the U S healthcare system.
