Eugia Pharma receives USFDA approval for Medroxyprogesterone Acetate Injectable Suspension

Image
Capital Market
Last Updated : Aug 24 2022 | 11:17 AM IST

Used for prevention of pregnancy

Aurobindo Pharma announced that its 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 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 specialty products.

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

Powered by Capital Market - Live News

Disclaimer: No Business Standard Journalist was involved in creation of this content

Subscribe to Business Standard digital and get complimentary access to The New York Times

Quarterly Starter

₹900

3 Months

₹300/Month

SAVE 25%

Smart Essential

₹2,700

1 Year

₹225/Month

Save 46%

Super Saver

₹3,900

2 Years

₹162/Month

Subscribe

Renews automatically, cancel anytime

Here’s what’s included in our digital subscription plans

Access to Exclusive Premium Stories Online

  • Over 30 behind the paywall stories daily, handpicked by our editors for subscribers

Complimentary Access to The New York Times

  • News, Games, Cooking, Audio, Wirecutter & The Athletic

Business Standard Epaper

  • Digital replica of our daily newspaper — with options to read, save, and share

Curated Newsletters

  • Insights on markets, finance, politics, tech, and more delivered to your inbox

Market Analysis & Investment Insights

  • In-depth market analysis & insights with access to The Smart Investor

Archives

  • Repository of articles and publications dating back to 1997

Ad-free Reading

  • Uninterrupted reading experience with no advertisements

Seamless Access Across All Devices

  • Access Business Standard across devices — mobile, tablet, or PC, via web or app

More From This Section

First Published: Aug 24 2022 | 10:35 AM IST

Next Story