Unichem Lab receives USFDA approval for Clonidine Hydrochloride Tablets

Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for Clonidine Hydrochloride Tablets USP, in the strengths of 0.1mg, 0.2mg and 0.3mg.

Clonidine Hydrochloride Tablets USP 0.1mg, 0.2mg and 0.3mg are therapeutically equivalent to CATAPRES Tablets USP 0.1mg, 0.2mg and 0.3mg from Boehringer Ingelheim.

Clonidine Hydrochloride has annual sales of approximately $334 million in the US. It is a low potent and popular molecule in the antihypertensive category.

The product will be now immediately commercialised from Unichem’s Goa Plant. Active pharmaceutical ingredient i.e. Clonidine Hydrochloride used for this ANDA is also made in house at Roha plant.

Unichem already has 6 other ANDAs duly approved and there are some more ANDAs in pipeline.