Aurobindo Pharma receives USFDA approval for Metronidazole tablets

By: |
June 02, 2015 12:10 PM

Metronidazole tablets are used to treat different types of infections

Metronidazole tablets are used to treat different types of infections

Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Metronidazole tablets USP 250mg and 500mg (ANDA 203974). Aurobindo will commence shipping shortly.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Flagyl tablets, 250mg and 500mg of GD Searle.

Metronidazole tablets are used to treat different types of infections which are due to particular types of bacteria and some other infectious organisms, or to prevent infection during an operation.

The product has an estimated market size of $58 million for the twelve months ending March 2015 according to IMS. This is the 37th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing oral non-betalactam products. Aurobindo now has a total of 194 ANDA approvals (167 Final approvals including nine from Aurolife Pharma and 27 tentative approvals) from US FDA.

Get live Stock Prices from BSE, NSE, US Market and latest NAV, portfolio of Mutual Funds, Check out latest IPO News, Best Performing IPOs, calculate your tax by Income Tax Calculator, know market’s Top Gainers, Top Losers & Best Equity Funds. Like us on Facebook and follow us on Twitter.

Financial Express is now on Telegram. Click here to join our channel and stay updated with the latest Biz news and updates.