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Lupin’s first generic approval in the Inhalation space
Mumbai, March 23, 2017: 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 5th and the 6th largest generics pharmaceutical company by market capitalization (December 31st, 2016, Bloomberg) and sales globally (September 30th, 2016, Bloomberg). The Company is the 5th largest pharmaceutical player in the US by prescriptions (4.68% market share – IMS Health, National Prescription Audit, March 2016); the 2nd largest Indian pharmaceutical company by revenues; the 6th 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 –
Head – Investor Relations and M&A
TOBI® is a registered trademark of Novartis AG.