Lupin Receives FDA Approval for Generic Mycobutin Capsules

Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Rifabutin Capsules USP, 150 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Pharmacia and Upjohn Company's Mycobutin® Capsules 150 mg. Lupin Pharmaceuticals Inc. (LPI), the company's US subsidiary would commence marketing the product shortly.

Lupin's Rifabutin Capsules, 150 mg are generic equivalent of Pharmacia And Upjohn Company's Mycobutin® Capsules 150 mg. Lupin's Rifabutin Capsules USP, 150 mg is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

Mycobutin® Capsules had annual U.S sales of US$ 18.6 million (IMS MAT Dec, 2013).

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 the 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 revenues. 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 http://www.lupinpharmaceuticals.com.

Lupin Appoints Dr. Maurice Chagnaud as President‐Europe & Head of Inhalation Strategy

Pharma major Lupin, today announced the appointment of Dr. Maurice Chagnaud as its President, Euroe and Head of Inhalation Strategy.  He will be based at Schaffhausen, Switzerland. Dr. Chagnaud has over 20 years of experience in Pharmaceutical business in Europe having worked with Teva and Merck Generics.He joins Lupin from Israeli drug major, Teva, where he was the Senior Vice President, Central & Eastern Europe, responsible for revenues in excess of over 1 Billion Euros.

In his new role at Lupin, Dr. Chagnaud will assume full responsibility for the Company’s European businss including the company strategy for Generics & Specialty business in Western and CEE region including Russia & CIS countries. He will also be responsible for developing Lupin’s core strategy for Inhalation in the developed markets.

Commenting on the appointment, Vinita Gupta, Chief Executive Officer, Lupin Limited said, “Over the years, Lupin has recorded consistent growth across advanced markets like the US and Japan. With Mauric’s rich experience  we  look  forward  to  building  our  business  in  Europe,  in  particular  around  Complex  generics & Specialty.  We are delighted to welcome him into the Lupin family.”

About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company producing and developing a wide rane 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 revenues. 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

Lupin launches Generic ZYMAXID™ Ophthalmic solution in the US

Lupin Pharmaceuticals Inc. (LPI), the US subsidiary of pharmaceutical major, Lupin Limited (Lupin), announced today that it has launched its generic Gatifloxacin Ophthalmic Solution, 0.5%. Lupin had earlier received final approval from the United States Food and Drugs Administration (US FDA) to market a generic version of Allergan Inc.'s Zymaxid™ Ophthalmic Solution, 0.5%.

Lupin's Gatifloxacin Ophthalmic solution 0.5% is the generic equivalent of Zymaxid™ Ophthalmic Solution of Allergan and is indicated for the treatment of bacterial conjunctivitis. Zymaxid™ Ophthalmic Solution, 0.5%, had annual U.S sales of approximately US$ 62.3 million (IMS MAT Jun 2013). Lupin was the first applicant to file an ANDA for Zymaxid™ Ophthalmic Solution and as such will be entitled to 180 days of marketing exclusivity.

Commenting on the approval, Nilesh Gupta, Managing Director, Lupin Limited said, "Having received approval earlier, we are happy to now launch this product. The product is the first of the ophthalmic products that Lupin is bringing to the market and bears testimony to our continued commitment to serving our customers and patients by bringing high quality, affordable medicines."

About Lupin Limited
Headquartered in Mumbai, 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.

Lupin Pharmaceuticals, Inc. is the wholly owned U.S. subsidiary of Lupin Limited. 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 http://www.lupinpharmaceuticals.com