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About Amlodipine Besylate API

Product
  • Therapeutic CategoryCardiovascular

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Mecanismo de acción

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specificion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected in vitro but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionized compound (pKa=8.6), and its kinetic interaction with the calcium channel receptor is characterized by a gradual rate of association and dissociation with the receptor binding site, resulting in a gradual onset of effect.

Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

The precise mechanisms by which amlodipine relieves angina have not been fully delineated, but are thought to include the following:

Exertional Angina: In patients with exertional angina, NORVASC reduces the total peripheral resistance (afterload) against which the heart works and reduces the rate pressure product, and thus myocardial oxygen demand, at any given level of exercise.

Vasospastic Angina: NORVASC has been demonstrated to block constriction and restore blood flow in coronary arteries and arterioles in response to calcium, potassium epinephrine, serotonin, and thromboxane A2 analog in experimental animal models and in human coronary vessels in vitro. This inhibition of coronary spasm is responsible for the effectiveness of NORVASC in vasospastic (Prinzmetal’s or variant) angina.

Indicación

NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

  • Hypertension
  • NORVASC is 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.
  • Coronary Artery Disease
  • Chronic Stable Angina
  • Vasospastic Angina (Prinzmetal’s or Variant Angina)
  • Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%

Experiencia de Dr. Reddy

Con sede en Hyderabad, India, Dr. Reddy's Laboratories es uno de los principales proveedores de ingredientes farmacéuticos activos (API) a nivel mundial. El negocio API de Dr. Reddy es considerado como un socio preferido de las compañías farmacéuticas en los Estados Unidos, Europa, Brasil, América Latina, Japón, China, Corea y los mercados emergentes.

El negocio de API de Dr. Reddy se nutre de las fortalezas técnicas profundas establecidas en los últimos 30 años en el desarrollo y fabricación de API complejas como esteroides, péptidos, moléculas complejas de cadena larga y API altamente potentes (HPAPI / medicamentos oncológicos). Esta experiencia se complementa con nuestra destreza en propiedad intelectual y asuntos regulatorios que nos ayudan a cumplir y superar los estándares regulatorios de manera consistente. Los APIs de Dr. Reddy´s Besilato De Amlodipino es el resultado de la amplia experiencia en R&D, IP y Normatividad Aplicable.

Un componente clave para ayudar a nuestros clientes a ser los primeros en comercializar es una cadena de suministro receptiva. Logramos esto al asegurarnos de que todas nuestras instalaciones funcionen de manera eficiente y con los últimos estándares de calidad, seguridad y productividad. Una fuerte interconexión entre las empresas y las fábricas permite una reacción rápida a los cambios dinámicos del mercado, de modo que podamos evitar la escasez y satisfacer los repentinos aumentos de la demanda.

RFQ Form

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FAQs

What is Amlodipine Besylate API used for?
  • Treats hypertension (high blood pressure) and angina (chest pain)

What is the dosage form and strength currently available for Amlodipine Besylate?
  • Available as oral tablets: 2.5 mg, 5 mg, 10 mg

What are the benefits of Amlodipine Besylate API?
  • Lowers blood pressure
    Reduces chest pain
    Improves blood flow to the heart

How do you store Amlodipine Besylate API?
  • Store at room temperature (20°C to 25°C), in a cool, dry place, away from light and moisture

Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.