Product/Composition:- | Amlodipine Besylate tablets |
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Strength:- | 5 mg, 10 mg |
Form:- | Tablet |
Reference Brands:- | Norvasc(US & EU) |
MOQ | As per the manufacturer batch size |
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Amlodipine tablets are calcium channel blockers that relax and widen blood vessels by inhibiting calcium entry into heart and vascular smooth muscle cells. Benefits include reducing blood pressure, alleviating angina, preventing strokes, and improving cardiovascular health by decreasing the workload on the heart and enhancing blood flow.
Amlodipine tablets are approved in both the US and EU, supported by comprehensive dossiers demonstrating safety, efficacy, and quality compliance with GMP standards. In the US, Norvasc (by Pfizer) is the approved branded product, while in the EU, both branded and generic versions are available. Regulatory processes include rigorous clinical evaluations and detailed documentation for market authorization. Dossiers encompass bioavailability, manufacturing practices, safety, and effectiveness data. For more information on licensing, regulatory requirements, and approved dossiers for amlodipine tablets, visit Pharmatradz. Stay updated on the latest global regulatory updates for amlodipine and its market access pathways.