Tags: Mumbai

Mumbai, Aug 19 Pharma major, Unichem Laboratories, has received an Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (US FDA) for Bisoprolol Fumarate tablets.

Bisoprolol Fumerage tablets USP 5 mg and 10 mg are therapeutically equivalent to Zebeta Tablets USP 5 mg and 10 mg from Duramed Pharmaeuticals. Bisoprolol Fumerate formulations have annual sales of approximately USD 50 million in the US, a company statement said.

Bisoprolol is a widely subscribed molecule in the anti-hypertensive category, the release said.

The product will be now 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 the company's Roha plant.

Unichem already has five other ANDAs duly approved and there are some more in the pipeline, the company said.

Unichem Laboratories is a specialty pharmaceutical company, manufacturing and marketing 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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