Unichem Laboratories has received FDA approval for bisoprolol fumarate tablets, for strengths of 5mg and 10mg.
Bisoprolol fumerage tablets are therapeutically equivalent to Duramed Pharmaceuticals’ Zebeta tablets. The company said that Bisoprolol is a widely prescribed molecule in the antihypertensive category.
The product will be commercialized from the company’s Goa plant. Active pharmaceutical ingredient, Bisoprolol fumarate used for this ANDA is also made in-house at the company’s Roha plant.
Unichem already has FDA approval for five other ANDA’s and few more ANDA’s are in pipeline.
Unichem Laboratories is a specialty pharmaceutical company. It manufactures and markets a basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets. The company is focussed at product development, process chemistry and manufacturing of complex API as well as dosage forms.