Oct 25, 2013, 05.48 PM IST
Unichem laboratories Limited are pleased to announce that it has received ANDA approval from the United States Food and Drug Administration for Amlodipine Besylate Tablets
Source: Business Wire India
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Unichem gets approval for Amlodipine Besylate Tablets
Unichem laboratories Limited are pleased to announce that it has received ANDA approval from the United States Food and Drug Administration for Amlodipine Besylate Tablets
Like this story, share it with millions of investors on M3
Unichem gets approval for Amlodipine Besylate Tablets
Unichem laboratories Limited are pleased to announce that it has received ANDA approval from the United States Food and Drug Administration for Amlodipine Besylate Tablets
Amlodipine Besylate Tablets USP 2.5mg, 5mg and 10mg are therapeutically equivalent to NORVASC® Tablets 2.5mg, 5mg and 10mg from Pfizer Inc.
Also read: US showing good growth; EMs steady: Unichem Labs
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 product will be commercialized from Unichem's Goa plant. Active pharmaceutical ingredient 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.
On October 25, 2013, Unichem Laboratories closed at Rs 170.50, up Rs 3.85, or 2.31 percent. The 52-week high of the share was Rs 216.80 and the 52-week low was Rs 138.00.
The company's trailing 12-month (TTM) EPS was at Rs 14.76 per share as per the quarter ended June 2013. The stock's price-to-earnings (P/E) ratio was 11.55. The latest book value of the company is Rs 89.75 per share. At current value, the price-to-book value of the company was 1.90.
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