Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for metronidazole USP tablets. Metronidazole USP tablets 250mg and 500mg are therapeutically equivalent to Flagyl tablets 250mg and 500mg of G D Searle LLC.
Metronidazole tablet USP is an anti-infective agent used to treat a variety of bacterial and protozoal infections. The product will be commercialized from Unichem’s Ghaziabad plant. Active pharmaceutical ingredient i.e., metronidazole used for this ANDA is also made in house at Roha plant.
Currently, around 6 other companies have generic approvals for the US market and the estimated market size is over US$ 100 million.