Lupin Receives Tentative FDA Approval For Generic Nudovra Tablets

Deepthi | Myequity news | Date : 23-08-2018 12:00:00 IST

Pharma major Lupin has received tentative approval for its Nudovra (Estradiol Valerate Tablets, 3 mg and 1 mg and Estradiol Valerate and Dienogest Tablets, 2 mg/2 mg and 2 mg/3 mg) Tablets from the United States Food and Drug Administration (FDA) to market a generic version of Bayer HealthCare Pharmaceuticals Inc.'s Natazia® Tablets.

Nudovra (Estradiol Valerate Tablets, 3 mg and 1 mg and Estradiol Valerate and Dienogest Tablets, 2 mg/2 mg and 2 mg/3 mg) Tablets had annual sales of approximately USD 31.4 million in the US (IQVIA MAT June 2018). It is an estrogen/progestin combined oral contraceptive (COC), indicated for use by women to prevent pregnancy.

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 8th largest generics pharmaceutical company both in terms of market capitalization (301h June 2018, Bloomberg) and revenues (31" March 2018, Bloomberg LTM) globally. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT June 2018); 3rd largest Indian pharmaceutical company by global revenues (31' March 2018, Bloomberg LTM); 5th largest generic pharmaceutical player in Japan and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT June 2018).For the financial year ended 31st March, 2018, Lupin's Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively.


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