Unichem Laboratories, a Mumbai based Rs 725 crore plus pharma major has received US FDA approval for clonidine hydrochloride tablets. These tablets are a low dose potent and popular molecule in the anti-hypertensive category. The company is commencing marketing of this product from its Goa plant. The API ingredient i.e. clonidine hydrochloride used for this ANDA will also made in house at Roha plant.
Clonidine hydrochloride tablets USP 0.1 mg, 0.2 mg and 0.3 mg are therapeutically equivalent to Catapres tablets from Boehringer Ingelheim. This formulation has annual sales of approximately USD 334 million in the US.
This approval will substantially increase the presence of Unichem in US market. Unichem already has 6 other ANDAs duly approved and there are some more ANDA's in pipeline.