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Lupin receives FDA approval for generic Seroquel XR® Tablets

 

Mumbai, May 18, 2017: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg from the United States Food and Drug Administration (FDA) to market a generic version of AstraZeneca Pharmaceuticals LP’s Seroquel XR® Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg.

Lupin’s Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg are the AB rated generic equivalent of AstraZeneca Pharmaceuticals LP’s Seroquel XR® Tablets 50 mg, 150 mg, 200 mg, 300 mg and 400 mg. It is indicated for the treatment of schizophrenia; acute manic or mixed episodes in bipolar I disorder alone or as an adjunct to lithium or divalproex; acute depressive episodes in bipolar disorder; maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder.

Seroquel XR® Extended-Release Tablets had US sales of USD 1.27 billion (IMS MAT March 2017).

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 5th and the 6th largest generics pharmaceutical company by market capitalization (December 31st, 2016, Bloomberg) and sales globally (September 30th, 2016, Bloomberg). The Company is the 5th largest pharmaceutical player in the US by prescriptions (4.3% market share – IMS MAT December 2016); the 2nd 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. You could also follow us on Twitter – www.twitter.com/lupinlimited

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 – For Lupin

Arvind Bothra Head – Investor Relations and M&A
Ph: +91-22-66402137
Email: arvindbothra@lupin.com

 *Safe Harbor Statement

Seroquel XR® is a registered trademark of the AstraZeneca UK Limited.