Leading global pharmaceutical company Lupin Limited (Lupin) has announced its receipt of approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for MinzoyaTM (Levonorgestrel and Ethinyl Estradiol Tablets, USP, and Ferrous Bisglycinate Tablets), 0.1 mg/0.02 mg and 36.5 mg, to market a generic equivalent of Balcoltra®(Levonorgestrel and Ethinyl Estradiol Tablets, USP, and Ferrous Bisglycinate Tablets) 0.1 mg/0.02 mg and 36.5 mg, of Avion Pharmaceuticals LLC. The manufacturing of the product will take place at Lupin’s Pithampur facility in India.
MinzoyaTM Tablets are intended for use by females of reproductive potential to prevent pregnancy.
The original drug, Levonorgestrel and Ethinyl Estradiol Tablets, USP, and Ferrous Bisglycinate Tablets (RLD Balcoltra®), had estimated annual sales of USD 42 million in the U.S. as of IQVIA MAT December 2023.
About Lupin: Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company’s diverse portfolio includes branded and generic formulations, biotechnology products, and APIs, catering to over 100 markets globally, including the U.S., India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.
With leadership positions in cardiovascular, anti-diabetic, and respiratory segments, Lupin also maintains a significant presence in anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. Recognized as the third-largest pharmaceutical company in the U.S. by prescriptions, Lupin demonstrates its commitment to innovation by investing 7.9% of its revenue in research and development during FY23.
With 15 manufacturing sites, 7 research centers, and a workforce of over 20,000 professionals globally, Lupin has consistently earned recognition as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
