Last updated on April 19, 2014 at 9:20 EDT

Lupin Receives FDA Approval for its New Drug Application for Antara® Capsules

October 22, 2013

MUMBAI, India and BALTIMORE, October 22, 2013 /PRNewswire/ –

Pharma Major Lupin Limited (Lupin) announced today that it has received final approval
for its supplemental New Drug Application (sNDA) for Antara(R) (Fenofibrate) capsules, 30
mg & 90 mg strengths from the United States Food and Drug Administration (FDA). Lupin
Pharmaceuticals Inc. (LPI), the company’s US subsidiary, will commence marketing the
product shortly. LPI currently markets and promotes Antara(R) Capsules, 43 mg & 130 mg
strengths. The new drug would be manufactured by Lupin.

Lupin’s Antara(R) capsules enjoy strong brand equity with primary care physicians
treating patients for high LDL-C, Total-C, triglycerides, Apo-B and low HDL-C. Antara(R)
capsules are prescribed for adjunct treatment of hypercholesterolemia (high blood
cholesterol), mixed dyslipidemia and hyper-triglyceridemia (high triglycerides) in
combination with diet.

Commenting on the approval, Vinita Gupta, Chief Executive Officer, Lupin Limited,
said, “We are very pleased to receive this approval. The approval demonstrates Lupin’s
commitment to building its brand franchise in the US. Our sales and marketing efforts will
commence shortly.”

About Lupin Limited

Lupin is an innovation-led transnational pharmaceutical company producing and
developing a wide range of branded and generic formulations 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 positions in the Anti-TB and
Cephalosporin segment.

Lupin is the 5th largest and fastest growing top 5 generics player in the US (5.3%
market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical
company by sales. The Company is also the fastest growing top 10 generic pharmaceutical
players in Japan and South Africa (IMS).

For the financial year ended March 2013, Lupin’s Consolidated turnover and Profit
after Tax were Rs. 94,616 million (USD 1.74 billion) and Rs. 13,142 million (USD 242
million) respectively. Please visit http://www.lupinworld.com for more information.

Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to
delivering high-quality, affordable generic medicines and branded formulations trusted by
healthcare professionals and patients across geographies. For more information, visit


For more information, please contact -

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

Safe Harbor Statement [http://www.lupinworld.com/safe harbor ]* Antara(R) Capsules is
the registered trademark of Lupin Pharmaceuticals Inc.

SOURCE Lupin Ltd

Source: PR Newswire