Lupin 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 $42 million in the U.S. (IQVIA MAT December 2023).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
Company Name | CMP |
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Sun Pharma Inds. | 1502.30 |
Dr. Reddys Lab | 6198.90 |
Cipla | 1402.20 |
Zydus Lifesciences | 957.00 |
Lupin | 1645.00 |
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