Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) 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.
The product will be commercialized from the company’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 $ 45-50 million.
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.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
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