Unichem Laboratories obtains ANDA approval from US FDA for metronidazole tablets

Unichem Laboratories has received ANDA approval from the US Food and Drug Administration (US FDA) for metronidazole USP tablets. Metronidazole USP tablets 250mg and 500 mg are therapeutically equivalent to flagyl tablets 250mg and 500 mg of GD Searle LLC. It is an anti-infective agent used to treat a variety of bacterial and protozoal infections.

The product will be commercialised 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 six other companies have generic approvals for the US market and the estimated market size is over $100 million.

EP News Bureau- Mumbai