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Lupin’s alliance partner Natco receives FDA approval for generic Fosrenol Chewable Tablets

 

Mumbai, August 14, 2017: Pharma major Lupin Limited (Lupin) and Natco announced the final ANDA approval of Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) from the United States Food and Drug Administration (FDA). The product, as the first generic, will be launched shortly.

Natco’s Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are generic equivalents of Shire Development LLC’s Fosrenol Chewable Tablets 500 mg, 750 mg and 1000 mg. Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).

Fosrenol Chewable Tablets has US sales of USD 122.4 million (IMS MAT June 2017). Lupin and Natco had entered into an agreement on September 01, 2008 to jointly commercialize generic equivalents of Fosrenol Chewable Tablets.

Commenting on the approval, Mr Nilesh Gupta, Managing Director, Lupin said, “We are very happy to finally be able to launch Lanthanum Carbonate Chewable Tablets in partnership with Natco. Lupin’s proven IP capabilities, marketing reach and expertise coupled with Natco’s solid development and manufacturing abilities make a great combination”. 

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 7th and 6th largest generics pharmaceutical company by market capitalization (June 30th, 2017, Bloomberg) and revenues (March 31st, 2017, Bloomberg) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (Quintiles IMS MAT March 2017); 2nd largest Indian pharmaceutical company by global revenues (March 31st, 2017, Bloomberg); 6th largest generic pharmaceutical player in Japan and 6th largest company in Indian Pharmaceutical Market (Quintiles IMS MAT June 2017).

For the financial year ended 31st March, 2017, Lupin’s Consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 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

Pooja ThakranVP – Corporate Communications
Ph: +91-22-66402531 / 8291013225
Email: poojathakran@lupin.com

Or

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

*Safe Harbor Statement

Fosrenol® is a registered trademark of Shire International Licensing BV.