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Lupin receives USFDA approval for generic version of Ortho-Cyclen Tablets

01 Nov 2016 Evaluate

Pharma major Lupin has received final approval for Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen 28 Tablets (Norgestimate/Ethinyl Estradiol). The approved product will be manufactured at Lupin’s Pithampur facility.

Lupin's Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg are the AB rated generic equivalent of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen 28 Tablets (Norgestimate/Ethinyl Estradiol). It is indicated for use by females of reproductive potential to prevent pregnancy. Ortho-Cyclen Tablets had US sales of $ 178.2 million as per IMS MAT June 2016.

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 Share Price

2377.90 -81.85 (-3.33%)
08-May-2026 16:59 View Price Chart
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Company Name CMP
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Dr. Reddys Lab 1293.25
Cipla 1347.70
Zydus Lifesciences 938.90
Lupin 2377.90
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