Aurobindo Pharma’s wholly owned subsidiary company -- Eugia Pharma Specialties has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL, 1 mL SingleDose Vial. Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL, 1 mL Single-Dose Vial to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Provera Injectable Suspension, of Pfizer Inc. The product will be launched in Q3FY23. The approved product has an estimated market size of around $ 62 million for the twelve months ending June 2022.
This is the 147 th ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
