Aurobindo Pharma gets USFDA nod for Medroxyprogesterone Acetate injectable suspension by admin- Wednesday, August 24th, 2022 02:49:31 PM
Aurobindo Pharma’s thoroughly owned subsidiary organisation, Eugia Pharma Specialties Ltd, obtained a final approval from the US Food & Drug Administration (USFDA) to fabricate 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 indexed drug (RLD), Depo-Provera Injectable Suspension, of Pfizer Inc. The product will be released in Q3 FY23. The approved product has an anticipated market size of around US$ 62 million for the 365 days ending June 2022.
This is the 147th ANDA (which includes 10 tentative approvals acquired) out of Eugia Pharma Speciality Group (EPSG) centers, production both oral and sterile area of expertise merchandise.