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Carvedilol

CAS No.

72956-09-3

Reference product

COREG/GSK

Polymorphic form

Form II

Therapeutic Area

Cardiovascular system

Status

commercial

EU DMF readiness

US DMF readiness

017060

CEP

Other documentation

Korean DMF
Japanese DMF

Drug description:

Carvedilol is a carbazole derivative acts as anti-hypertensive agent.
Carvedilol is indicated for the management of essential hypertension. It is also indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction. Carvedilol is also indicated for the treatment of tachycardiac atrial fibrillation.
It is formulated as tablets or film coated tablets for oral route of administration.

Mechanism of action:

Carvedilol acts as a nonselective beta-adrenoceptor blocking agent and as an alpha 1-adrenoceptor blocker. It’s beta-adrenergic receptor (beta-1 and beta-2 adrenergic receptors) blocking ability decreases the heart rate, myocardial contractility, and myocardial oxygen demand. Carvedilol also decreases systemic vascular resistance via its alpha adrenergic (alpha-1) receptor blocking properties. Carvedilol and its metabolites also prevent OH- radical-induced decrease in sarcoplasmic reticulum Ca2+-ATPase activity. Therefore, carvedilol and its metabolites may be beneficial in chronic heart failure by preventing free radical damage.

Disclaimer
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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