Unichem Pharma gets nod from USFDA for Bisoprolol Fumarate Tablets
US-based Unichem Pharma, a wholly owned subsidiary of Unichem Laboratories has finally secured nod from US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Bisoprolol Fumarate tablets.
The drug is the generic version of Duramed Pharmaceuticals' Zebeta Tablets USP 5 milligram (mg) and 10 mg.
Bisoprolol is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents. The drug has an annual sale of approximately $50 million in the US market.
Earlier this year in March, the company received US FDA approval for Topiramate tablets in multiple strengths.
Unichem Laboratories is engaged in manufacturing and marketing pharmaceutical formulations, bulk drugs and drug intermediates.
The company has registered a decline of 2.97% in its net profit, and 6.97% fall in net sales in Q1 June 2009 over Q1 June 2008.