drugset / Press release

Sun Pharma announces USFDA approval for Sinemet CR, an extended release version of Carbidopa with Levodopa

2007-08-25 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400 093 India Tel.: (91-22) 6645 5645 Fax.: (91-22) 6645 5685 Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. PRESS RELEASE Sun Pharma announces USFDA approval to market generic Sinemet CR® Tablets Mumbai, August 25, 2007: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the company’s Abbreviated New Drug Applic ation (ANDA) for generic Sinemet CR, an extended release version of carbidopa with levodopa. Carbidopa with levodopa extended release is indicated for the treatment of Parkinson’s disease and syndrome. These generic extended release versions of carbidopa with levodopa are bio-equivalent to Sinemet CR® marketed by Bristol-Myers and Squibb Company and will be available as tablets in two strengths: 25 mg carbidopa with 100 mg levodopa and 50 mg carbidopa with 200 mg levodopa. These strengths of carbidopa with levodopa generic and branded products had annual sales of approximately USD 66 million in the US. The Company expects to reach the market shortly with these products. Sinemet CR® is a registered trademark of Merck & Co., Inc. About Sun Pharma Established in 1983, listed since 1994 and headquartered in Indi a, Sun Pharma (Reuters: SUN. BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical 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, neur ology, cardiology, diabetology, gastroenterology, and orthopedics. 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 www.sunpharma.com. Contacts Uday Baldota Mira Desai Tel +91 22 6645 5645, Xtn 605 Tel +91 22 6645 5645, Xtn 606 Tel Direct +91 22 66455605 Tel Direct +91 22 66455606 Mobile +91 98670 10529 Mobile +91 98219 23797 E mail [email protected] E mail [email protected]

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