Pharma manufacturign company, Unichem Laboratories has announced that it has received Abbreviated New Drug Abbreviation (ANDA) approval from the United States Food and Drug Administration (USFDA) for clonidine hydrochloride tablets.
Clonidine hydrochloride formulations have annual sales of approximately USD 334 million in the US, a company statement said here. 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, it said. Clonidine Hydrochloride is a low dose potent and popular molecule in the antihypertensive category.
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. This ANDA approval will substantially increase the presence of Unichem in US market. Unichem already has six other ANDAs duly approved and there are few more in pipeline.
Unichem Laboratories manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, orthopedics and anti-infectives.
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