USFDA grants tentative approval for Sun Pharma's ANDA for Galantamine tablets

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 tentative approval for generic Razadyne tm Tablets Mumbai, August 30, 2007: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted tentative approval for the company’s Abbreviated New Dr ug Application (ANDA) for generic Razadyne tm, galantamine tablets. Galantamine is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. These generic versions of galantamine are bio-equivalent to Razadyne tm distributed by Ortho-McNeil Neurologics, Inc. The ANDA includes three strengths: tablets containing galantamine hydrobromide equivalent to 4mg, 8 mg and 12 mg base. These strengths of branded galantamine have annual sales of approximately USD 120 million in the US. Razadyne tm is a trademark of Johnson & Johnson. 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, 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 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]

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