Mumbai, Baltimore, August 01, 2023: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Turqoz® (Norgestrel and Ethinyl Estradiol Tablets USP)0.3 mg/0.03 mg, to market a generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets)0.3 mg/0.03 mg of Wyeth Pharmaceuticals LLC. This product will be manufactured at Lupin’s Pithampur facility in India.
Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual saleof USD 34 million in the U.S. (IQVIA MATMar 2023).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
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