In the pharmaceutical industry, Amlodipine tablets (available in 2.5 mg, 5 mg, and 10 mg) are a leading long-acting calcium channel blocker (CCB) of the dihydropyridine class. As a pharmacist, I consider Amlodipine a foundational treatment for cardiovascular health due to its high bioavailability and consistent 24-hour efficacy.
Primary Clinical Uses
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Hypertension (High Blood Pressure): It is a first-line therapy to lower blood pressure, which significantly reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
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Chronic Stable Angina: Used to prevent the chest pain associated with coronary artery disease by improving blood flow to the heart muscle.
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Vasospastic Angina (Prinzmetal’s Angina): Specifically indicated for treating chest pain caused by spasms of the coronary arteries.
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Coronary Artery Disease (CAD): In patients with recently documented CAD by angiography, Amlodipine is used to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
Mechanism of Action
Amlodipine works by inhibiting the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It specifically targets “L-type” calcium channels. By preventing calcium from entering these cells, it causes the blood vessels to relax and dilate (vasodilation). This action decreases total peripheral resistance (afterload), which lowers blood pressure and reduces the workload on the heart.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing and global trade standpoint, Amlodipine Besylate is a robust, high-demand molecule that requires technical precision:
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Salt Selection (Besylate vs. Maleate): We primarily manufacture the Besylate salt due to its superior stability and compatibility profile during the compression process, ensuring a longer shelf life for international transit.
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Photo-Stability: Amlodipine is sensitive to light. As a WHO-GMP manufacturer, we utilize opaque blister packaging and light-resistant coating techniques to maintain the integrity of the active pharmaceutical ingredient (API).
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Global Export Reach: Because hypertension is a global health priority, Amlodipine is a staple for our B2B partners and government tenders. Our facility in Mumbai is optimized for the high-capacity production required for these recurring global orders.
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Regulatory Compliance: We provide comprehensive CTD/eCTD Dossiers, including comparative dissolution studies, to ensure our partners meet the bioequivalence requirements for registration in markets across Africa, the Middle East, and Southeast Asia.