Domestic pharmaceutical major Dr Reddy's Laboratories Ltd has finally received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application or ANDA, for its over-the-counter drug Omeprazole Mg.

Omeprazole is the generic version of AstraZeneca PLC's Prilosec. It is indscated for the treatment of dyspepsia, peptic ulcer disease (PUD), gastroesophageal reflux disease (GORD/GERD) and Zollinger-Ellison syndrome.

The Hyderabad, India-based company said that first shipment of Omeprazole Mg would start during the second quarter of the next year (2010).

Dr Reddy's, in May 2009, estimated 10% revenue growth during the year to March 2010. It also said that the U.S. launch of Omeprazole would also help a lot in achieving this target.

Dr. Reddy’s Laboratories, on June 08, announced that its wholly owned US division has got final nod from USFDA to make and sell (on prescription basis) Glyburide and Metformin Hydrochloride tabs in the strength of 1.25mg /250 mg; 2.5mg/500mg and 5mg/500mg.

Moreover, the company also received final approval from USFDA to manufacture and market Ranitidine syrup in strength of 15 mg/ ml syrup during the last month.

Shares of the company, on Tuesday (June 09), closed at Rs 711.40, up 3.7%, on the Bombay Stock Exchange (BSE). Current EPS and P/E of the stock stood at 32.39 & 21.97 respectively. The share price has seen a 52-week high of Rs 730 and a low of Rs 357 on BSE.