Aurobindo Pharma arm bags USFDA nod for Medroxyprogesterone Acetate Injectable Suspension

Published On 2022-08-24 06:55 GMT   |   Update On 2022-08-24 07:07 GMT

Hyderabad: Drugmaker, Aurobindo Pharma Limited, today announced that its wholly-owned subsidiary company, Eugia Pharma Specialties Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL, 1 mL single dose Vial.Medroxyprogesterone Acetate Injectable Suspension USP,...

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Hyderabad: Drugmaker, Aurobindo Pharma Limited, today announced that its wholly-owned subsidiary company, Eugia Pharma Specialties Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market 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 to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Provera Injectable Suspension, of Pfizer Inc.

Medroxyprogesterone Acetate Injection is indicated for use by females of reproductive potential to prevent pregnancy.

Read also: Aurobindo Pharma arm bags USFDA okay for Triamcinolone Acetonide Injectable Suspension

The product will be launched in Q3 FY23. The approved product has an estimated market size of around US$ 62 million for the twelve months ending June 2022, according to IQVIA.

This is the 147th ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile speciality products.

Read also: USFDA nod to Aurobindo Pharma arm's Vasopressin Injection

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 155 countries. The company has 27 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company's product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic.
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