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Lupin Receives FDA Approval for Generic Namenda XR® Capsules

 

Mumbai, Baltimore, Sept 29, 2016: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, and 28 mg from the United States Food and Drug Administration (FDA) to market a generic version of Allergan’s Namenda XR® Capsules, 7 mg, 14 mg, 21 mg, and 28 mg.

Lupin's Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, and 28 mg are the AB rated generic equivalent of Allergan’s Namenda XR® Capsules, 7 mg, 14 mg, 21 mg, and 28 mg.

Memantine Hydrochloride Extended-Release Capsules, 7 mg, 14 mg, 21 mg, and 28 mg are indicated for treatment of moderate to severe dementia of the Alzheimer's type.

Namenda XR® Capsules had US sales of USD 1.22 Billion (IMS MAT June 2016).

About Lupin Limited

Lupin is an innovation led transnational pharmaceutical company developing and delivering 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 7th and the 9th largest generics pharmaceutical company by market capitalization and sales globally (March 31st, 2016, Bloomberg). The Company is the 5th largest pharmaceutical player in the US by prescriptions (4.68% market share – IMS Health, National Prescription Audit, March 2016); the 3rd largest Indian pharmaceutical company by revenues; the 6th 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 sales and Net profit stood at Rs. 136,539 million (USD 2.09 billion) and Rs. 22,607 million (USD 345 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

Namenda XR® is the registered trademark of Allergan plc.