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Lupin Receives Tentative Approval for Generic Lexiva® Tablets, 700 mg from US FDA

 

Mumbai, Baltimore, July 27, 2016: Pharma Major Lupin Limited (Lupin) announced today that its US subsidiary, Lupin Pharmaceuticals Inc. has received tentative approval from the United States Food and Drug Administration (FDA) to market a generic equivalent of ViiV Healthcare’s (ViiV) Lexiva® Tablets, 700 mg (Fosamprenavir Calcium Tablets, 700 mg). This product was filed from Lupin’s Goa formulations manufacturing facility.

Lupin’s Fosamprenavir Calcium Tablets, 700 mg are the AB rated generic equivalent of ViiV Healthcare’s Lexiva® Tablets. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Lexiva® Tablets had US sales of USD 71.6 million (IMS MAT March 2016).

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 position in the Anti-TB segment.

Lupin is the 5th largest generics player in the US (5.51% generic market share by prescriptions – IMS Health, National Prescription Audit, MAT March 2016) and the 2nd largest Indian pharmaceutical company by market capitalization. The Company is also the 9th largest generic pharmaceutical player in Japan and the 4th largest generic pharmaceutical company in South Africa (IMS Health, March 2016). For the financial year ended 31st March, 2016, Lupin’s Consolidated turnover and Profit after Tax stood at Rs. 137,016 million (USD 2.09 billion) and Rs. 22,707 million (USD 347 million) respectively. Please visit http://www.lupin.com for more information.

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CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, off Western Express Highway, Santacruz (East), Mumbai 400 055.

For further information or queries please contact –

Shamsher Gorawara
Head – Corporate Communications
Ph: +91-98 20 338 555
Email: shamshergorawara@lupin.com

*Safe Harbor Statement

Lexiva® is the registered trademark of ViiV Healthcare Group of Companies.