Monday, September 16, 2013

Sun Pharma announces USFDA approval for generic Prevacid®

Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) today announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Applications (ANDA) for generic version of Prevacid®, Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg.Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg are therapeutic equivalents of Takeda’s Prevacid®

Delayed-Released Capsules. These Capsules have annual sales of approximately USD 430 million in the US.Lansoprazole Delayed-Release Capsules USP are indicated for short-term treatment (for 4 weeks) for healing andsymptom relief of active duodenal ulcer.

Prevacid® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc.

About Sun Pharmaceutical Industries Ltd.
Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd.(Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, USand several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology, orthopedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at