Mumbai, Baltimore: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Blisovi 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg) from the United States Food and Drug Administration (FDA) to market a generic version of Warner Chilcott’s Loestrin®24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg). Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. would commence promoting the product shortly in the US.
Lupin’s Blisovi 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg) are the AB rated generic equivalent of Warner Chilcott’s Loestrin®24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg). It is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
Loestrin®24 Fe had US sales of $56.8 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 ($2.06 billion) and . 24,032 million ($393 million) respectively.
Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited
CIN: L24100MH1983PLC029442 Registered Office: 159, C.S.T. Road, Kalina, Santacruz (East), Mumbai – 400 098
For more information, please contact –
Shamsher Gorawara Head – Corporate Communications Ph: +91-22- 98 20 338 555 Email: shamshergorawara@lupin.com
Or
Alpesh Dalal Head – M & A and Investor Relations Lupin Limited Ph: +91 98 20 023 511 Email: alpeshdalal@lupin.com
