Lupin receives FDA approval for generic Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram
Mumbai, Baltimore, June 04, 2018: Pharma major Lupin announced that it has received final approval for its Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, from the United States Food and Drug Administration (FDA) to market a generic version of Delcor Asset Corporation’s (Delcor) Mycolog®-II Cream.
Lupin’s Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, is the generic equivalent of Delcor’s Mycolog®-II Cream. It is indicated for the treatment of cutaneous candidiasis.
Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, had annual sales of approximately USD 62.2 million in the US (IQVIA MAT April 2018).
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 12th and 8th largest generics pharmaceutical company by market capitalization (March 31st, 2018, Bloomberg) and revenues (December 30th 2017, Bloomberg LTM) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT March 2018); 3rd largest Indian pharmaceutical company by global revenues (December 30th 2017, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT March 2018).
For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits were at Rs. 155,598 million (USD 2.41 billion) and Rs. 2,513 million (USD 39 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinglobal
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 –
VP – Corporate Communications
Ph: +91-22-66402531 / 8291013225
Head – Investor Relations
Mycolog®-II is a registered trademark of Delcor Asset Corporation