Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord)announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg, to market the generic equivalent of Myfortic® Delayed-Release Tablets, 180 mg and 360 mg, of Novartis Pharmaceuticals Corporation.
Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg, are indicated for:
- Prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant.
- Use in combination with cyclosporine and corticosteroids.
Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg(RLD: Myfortic®) had an annual sales of approximately USD 174million 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 163,694million (USD 2.34 billion) and INR 9,466 million (USD 136 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter at – www.twitter.com/lupinglobal
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rdFloor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
Head – Investor Relations and M&A / Corporate Communications
Myfortic® is a registered trademark of Novartis AG Corporation Switzerland