Mumbai, Baltimore: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Bimatoprost Ophthalmic Solution, 0.03% from the United States Food and Drugs Administration (FDA) to market a generic version of Allergan Inc.’s Lumigan® Ophthalmic Solution, 0.03%. Lupin Pharmaceuticals Inc. (LPI), the company’s US subsidiary would commence marketing the product shortly.
Lupin’s Bimatoprost Ophthalmic Solution, 0.03% is the AT rated generic equivalent of Lumigan® Ophthalmic Solution, 0.03% and is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Lupin’s Bimatoprost Ophthalmic Solution, 0.03% filing was made from its Indore facility which was audited in January, 2015. Two Lupin facilities, the Lupin Bioresearch Center, Pune (LBC) and its manufacturing facility at Pithampur, near Indore were audited by the US FDA in November, 2014 and January, 2015 respectively. Both the audits were completed successfully with LBC not receiving any observations and the Indore facility receiving six observations (483’s). Since then, the Indore facility has received 1 ANDA approval and 2 site-transfer approvals.
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations as well as 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 5th largest and fastest growing top 5 generics player in the US (5.3% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also amongst the top 10 generic pharmaceutical players in Japan and South Africa (IMS). For the financial year ended March 2014, Lupin’s Consolidated revenues and Profit after tax were Rs. 110,866 million (USD 1.83 billion) and Rs. 18,364 million (USD 304 million) respectively. Please visit http://www.lupin.com for more information.
CIN: L24100MH1983PLC029442 Registered Office: 159, C.S.T. Road, Kalina, Santacruz (East), Mumbai – 400 098.
About Lupin Pharmaceuticals Inc.
Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients across geographies. For more information, please do visit http://www.lupinpharmaceuticals.com
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