Unichem Laboratories Ltd, a Rs 725 crore plus pharma company, has received US FDA approval for bisoprolol fumarate tablets USP, 5mg and 10mg.
Bisoprolol fumerage tablets USP 5mg and 10mg are therapeutically equivalent to Zebeta tablets USP 5mg and 10mg from Duramed Pharmaceuticals. Bisoprolol fumarate formulations have annual sales of approximately USD 50 million in the US. Bisoprolol is a widely prescribed molecule in the antihypertensive category.
According to a company release, the product will be immediately commercialized from the company's Goa plant. Active pharmaceutical ingredient i.e. bisoprolol fumarate used for this ANDA is also made in-house at Roha plant. This will substantially increase the presence of Unichem in US market.
Unichem already has US FDA approval for five other ANDA's and few more ANDA's are in pipeline.