drugset / Press release

Sun Pharma announces USFDA approval for generic Prandin®

2013-07-12 · 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 Prandin ® Company has 180-day marketing exclusivity Mumbai, July 12, 2013: Sun Pharmaceutical Industrie s 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 Prandin®, Repaglinide tablets. Repaglinide tablets, 1 mg and 2 mg are therapeutic equivalents of Novo Nordisk’s Prandin ® tablets. These tablets have annual sales of approximately USD 200 million in the US. Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. Sun Pharma’s subsidiary, being the first-to-file an ANDA for generic Prandin ® with a para IV certification, is eligible for a 180-day marketing exclusivity in the US. Prandin ® is a registered trademark of Novo Nordisk A/S. About Sun Pharmaceutical Industries Ltd. Established in 1983, listed since 1994 and headquar tered in India, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, specialty pharmaceut ical company. It manufactures and markets a large basket of pharmace utical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology, orthopedi cs and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing o f complex API, as well as dosage forms. More inform ation 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 66455 606 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 ↗