Amlodipine Besylate tablets

Form: Tablet

Strength: 5 mg, 10 mg

Reference Brands: Norvasc(US & EU)

Category: Medical Aid

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.