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Lupin Receives Tentative Approval for Generic Zithromax® Oral Suspension

 

Mumbai, September 1, 2016: Pharma Major Lupin Limited announced today that its US subsidiary, Gavis Pharmaceuticals LLC., U.S.A. (collectively Lupin) has received tentative approval for its Azithromycin for oral suspension USP, 300 mg (100 mg/5 mL) and 1200 mg (200 mg/5 mL) from the United States Food and Drug Administration (FDA) to market a generic version of Pfizer Inc.’s Zithromax® for oral suspension, 100 mg/5ml and 200 mg/5ml. Lupin had earlier received final approval for its Azithromycin Tablets, 250 mg, 500 mg, 600 mg and Azithromycin for Oral Suspension USP, 100 mg/5 mL and 200 mg/5 mL from the FDA which was filed from its Goa plant.

Azithromycin for oral suspension USP, 300 mg (100 mg/5ml) and 1200 mg (200 mg/5ml) per bottle are the AB rated generic equivalent of Pfizer Inc.’s Zithromax® for oral suspension, 100 mg/5ml and 200 mg/5ml. It is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria.

Zithromax® Oral Suspension had US sales of USD 110.6 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 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 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
Lupin Limited 
Ph: +91 98 20 338 555
Email: shamshergorawara@lupin.com

 *Safe Harbor Statement

Zithromax® is the registered trademark of Pfizer Inc.