Lupin Receives Tentative Approval for Generic Rapaflo® Capsules


Mumbai, Baltimore, September 06, 2016: Pharma Major Lupin Limited (Lupin) announced today that it has received tentative approval for its Silodosin Capsules, 4 mg and 8 mg from the United States Food and Drug Administration (FDA) to market a generic version of Allergan Sales, LLC’s Rapaflo® Capsules, 4 mg and 8 mg.

 Lupin’s Silodosin Capsules, 4 mg and 8 mg are the AB rated generic equivalent of Allergan Sales, LLC’s Rapaflo® Capsules, 4 mg and 8 mg. It is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia.

Rapaflo® had US sales of USD 228.7 million (IMS MAT June 2016).

About Lupin Limited

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 pharmaceutical player in the US (4.68% 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 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 –

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

*Safe Harbor Statement

Rapaflo® is the registered trademark of Actavis Inc.