Aurobindo Pharma's WOS gets USFDA Approval for Medroxyprogesterone Acetate

24 Aug 2022 , 03:29 PM

Aurobindo Pharma Limited announced that Eugia Pharma Specialties Limited, its wholly owned subsidiary has received final FDA clearance to manufacture and commercialize Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL, 1 mL single dose Vial.

Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL, 1 mL Single-Dose Vial is bioequivalent and medically equivalent to Pfizer Inc.’s Depo-Provera Injectable Suspension.

The product will be available in the third quarter of FY23. According to IQVIA, the authorized product has a market size of roughly US$ 62 million for the period ending June 2022.

This is the 147 ANDA (including ten tentative approvals) received by Eugia Pharma Speciality Group (EPSG) facilities, which manufacture both oral and sterile specialty pharmaceuticals.

At around closing, Aurobindo Pharma was trading at Rs559.75 up by 0.03% from its previous closing of Rs559.60 on the BSE.

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