Mumbai, Baltimore: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Donepezil Hydrochloride Tablets, 23 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eisai Inc.’s Aricept®, Tablets, 23mg. Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. would commence promoting the product shortly in the US.
Lupin’s Donepezil Hydrochloride Tablets, 23 mg are the AB rated generic equivalent of Eisai Inc.’s Aricept®, Tablets, 23mg and is indicated for the treatment of dementia of the Alzheimer’s type. Aricept®, had US sales of USD 52.3 million (IMS MAT June 2015).
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.
Lupin is the 6th largest and fastest growing top 10 generics player in the US (5.5% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales globally. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan (ranked 8th) and South Africa (ranked 4th – IMS Health). For the financial year ended 31st March 2015, Lupin’s Consolidated turnover and Profit after Tax were . 125,997 million (USD 2.06 billion) and . 24,032 million (USD 393 million) respectively.
CIN: L24100MH1983PLC029442 Registered Office: 159, C.S.T. Road, Kalina, Santacruz (East), Mumbai – 400 098
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