Sun Pharma gets USFDA approval for generic Fosamax® tablets
2008-09-12 · 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 Registered Office : SPARC, Tandalja, Vadodara – 390 020. India FOR IMMEDIATE RELEASE Sun Pharma gets USFDA approval for generic Fosamax ® tablets Mumbai, September 12, 2008: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for generic Fosamax ®, alendronate sodium tablets. Alendronate sodium tablets are indicated for the treatmen t and prevention of osteoporosis in post menopausal women, to increase bone mass in men with osteoporosis, in the treatment of glucocorticoid induced osteoporosis, and Paget’s disease of the bone in men and women. These generic versions of alendronate sodium tablets 5 mg (base), 10 mg (base), 35 mg (base) and 70 mg (base) are bio-equivalent to Fosamax ® tablets distributed by Merck & Co. These strengths of Fosamax ® tablets have annual sales of approximately USD 560 million in the US. These products will reach market shortly. Fosamax ® is a registered trademark of Merck & Co. About Sun Pharmaceutical Industries Ltd. Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Indust ries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) is an international, integrated, sp eciality 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 company is a leader in niche therapy areas of psychiatry, neurology, 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 abou t 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] Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. India
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