Sun Pharma announces USFDA tentative approval for generic Aricept®
2010-11-30 · 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 Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. India FOR IMMEDIATE RELEASE Sun Pharma announces USFDA tentative approval for generic Aricept® Mumbai, November 30, 2010: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted a tentative approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Aricept®, donepezil hydrochloride tablets. These generic donepezil hydrochloride tablets, equivalent to Eisai’s Aricept® tablets, include two strengths: 5 mg and 10 mg. Annual sale in US for these strengths is approximately $ 2.5 billion. Donepezil hydrochloride tablets are indicated in the treatment of dementia of the Alzheimer’s type. Efficiency has been demonstrated in patients with mild, moderate and severe Alzheimer’s disease. Aricept® is a registered trademark of Eisai co. Ltd. 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 internat ional, integrated, speciality 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, ophthalmology and orthopedics. The company has st rong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage form s. 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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