drugset / Press release

Sun Pharma announces USFDA approval for generic Prevacid®

2013-09-14 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

Sun Pharmaceutical Industries Ltd. 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400 093 India Tel.: (91-22) 6645 5645 Fax.: (91-22) 6645 5685 Registered Office : SPARC, Tandalja, Vadodara – 390 020. India Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. India FOR IMMEDIATE RELEASE Sun Pharma announces USFDA approval for generic Prevacid® Mumbai, September 14, 2013: 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 (A NDA) 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 annu al 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 and symptom 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 Indi a, Sun Pharmaceutical Indust ries 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 formulat ions as branded generics as well as generics in India, US and several other markets across the world. In India, the compan y is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastro enterology, orthopedics and ophthalmology. The company has strong skills in product development, process chemistry, and manu facturing of complex API, as well as dosage forms. More information about the company can be found at www.sunpharma.com. Contacts Nimish Desai Mira Desai Tel +91 22 6645 5645, Xtn 717 Tel +91 22 6645 5645, Xtn 606 Tel Direct +91 22 66455717 Tel Direct +91 22 66455606 Mobile +91 98203 30182 Mobile +91 98219 23797 E mail [email protected] E mail [email protected]

The release as fetched from its publisher. sunpharma.com ↗