Unichem stock surges 4% on US FDA approval

unichem
Shares in Unichem Laboratories rallied after the company said it has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Amlodipine Besylate Tablets.

The stock was last trading at Rs 173, up almost 4% over yesterday's close on the National Stock Exchange.

"Amlodipine Besylate Tablets USP 2.5mg, 5mg and 10mg are therapeutically equivalent to NORVASC Tablets 2.5mg, 5mg and 10mg from Pfizer Inc.

Amlodipine Besylate Tablet USP is a calcium channel blocker indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions," the company has stated in a release.

The product will be commercialized from Unichem's Goa plant. Active pharmaceuticalingredient i.e., Amlodipine Besylate used for this ANDA is also made in house at Roha plant.

Currently, there are 6-7 companies are dominating the US market. The current market size is around US$ 45~50 Million.

Unichem Laboratories Limited is an International, integrated, speciality pharmaceutical Company. It manufactures and markets 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 leaded in niche areas of cardiology, neurology and other orthopadics and anti-infectives. The Company has strong skills in product development, process chemistry and manufacturing of complex API as well as dosage forms.

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