Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from the US Food and Drug Administration for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Laboratories said in a statement.
If it gets the USFDA nod, the sales would help to pull the company out of the red.
Ranbaxy was scheduled to launch its drug on September 21, the day Diovan's patent expired.
FDA inspectors visited the Mohali plant in the process of giving approval to Ranbaxy's application for Valsartan.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
BSE Midcap and Smallcap indices ended in line with their larger counterparts and closed marginally up 0.2% and 0.4%, each
Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
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