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Hydrochlorothiazide

CAS No.

58-93-5

Reference product

ESIDREX/NOVARTIS

Polymorphic form

Form I

Therapeutic Area

Cardiovascular system

Status

commercial

EU DMF readiness

US DMF readiness

017599

CEP

Other documentation

Japanese DMF
Chinese DMF
Korean DMF
Canadian DMF
Brazilian DMF

💉 Available also
in injectable form

Drug description:

Hydrochlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. It has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. It is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.

Mechanism of action:

Hydrochlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption. Hydrochlorothiazide increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate.

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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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