Lupin’s first generic approval in the Inhalation space

Mumbai: Pharma Major Lupin Limited (Lupin) announced today that it has received final approval for its Tobramycin Inhalation Solution USP, 300 mg/5 ml from the United States Food and Drug Administration (FDA) to market a generic version of Novartis Pharmaceuticals Corporation’s TOBI® 300 mg/5 ml.

Lupin’s Tobramycin Inhalation Solution USP, 300 mg/5 ml is the AN rated generic equivalent of Novartis Pharmaceuticals Corporation’s TOBI® 300 mg/5 ml. It is indicated for the management of cystic fibrosis patients with P. aeruginosa.

Tobramycin Inhalation Solution USP, 300 mg/5 ml had US sales of USD 133.6 million (IMS MAT December 2016).

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 5

Lupin is the 5^th and the 6^th largest generics pharmaceutical company by market capitalization (December 31^st, 2016, Bloomberg) and sales globally (September 30^th, 2016, Bloomberg). The Company is the 5^th largest pharmaceutical player in the US by prescriptions (4.68% market share – IMS Health, National Prescription Audit, March 2016); the 2^nd largest Indian pharmaceutical company by revenues; the 6^th largest generic pharmaceutical player in Japan and the 4^th largest generic pharmaceutical company in South Africa (IMS Health, March 2016).

For the financial year ended 31^st 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, 3^rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055. 

For further information or queries please contact – 

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

 *Safe Harbor Statement

TOBI® is a registered trademark of Novartis AG.