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Mumbai - Glenmark Generics Ltd, a unit of India's Glenmark Pharmaceuticals Ltd, has received the nod from the US Food and Drug Administration (USFDA) for the sale of its generic version of anti-hypertension drug, Trandolapril.
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Trandolapril is an ACE inhibitor used to treat high blood pressure. It acts by competitive inhibition of Angiotensin Converting Enzyme (ACE), a key enzyme in the renin-angiotensin system (RAS pathway) which plays an important role in regulating blood pressure.
It is sold by Abbott Laboratories under the name Mavik.
In the 12 months to March 2008, Trandolapril has generated sales of $23 million, according to IMS data, Glenmark said in a statement.
The abbreviated new drug application (ANDA) approval is for Trandolapril tablets USP 1 mg, 2 mg and 4 mg, the company said, adding it would begin marketing and distribution of its generic version of Trandolapril tablets in the US market.
While the USFDA has approved 33 generic products of Glenmark for distribution in the US market, there are over 35 pending ANDAs filed with the USFDA, the pharmaceutical major said.
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