Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Diprolene® Ointment, 0.05%, of Merck Sharp and Dohme Corp. The product will be manufactured at Lupin’s Pithampur (Unit 3) facility, India.
Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older.
Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, (RLD: Diprolene®) had an annual sales of approximately USD 22 million in the U.S. (IQVIA MAT September 2019).
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biosimilar 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 8th largest generics pharmaceutical company by revenues (June 30, 2019, Bloomberg LTM). The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT September 2019); 3rd largest Indian pharmaceutical company by global revenues (June 30, 2019, Bloomberg LTM) and 6th largest company in the Indian pharmaceutical market (IQVIA MAT September 2019).
For the financial year ended March 31, 2019, Lupin’s Consolidated sales and Net profits before exceptional items were at INR 163,694 million (USD 2.34 billion) and INR 9,466 million (USD 136 million) respectively.
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
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Head – Investor Relations and M&A / Corporate Communications
Diprolene® is a registered trademark of Merck Sharp and Dohme Corp