Global pharma major Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Minzoya (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 product will be manufactured at Lupin’s Pithampur facility in India.

Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets (RLD Balcoltra) had estimated annual sales of US $42 million in the U.S. (IQVIA MAT December 2023).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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.