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Clopamide

CAS No.

636-54-4

Reference product

Brinaldix/NOVARTIS

Polymorphic form

Polymorphic form

Therapeutic Area

Cardiovascular system

Status

commercial

EU DMF readiness

Drug description:

Clopamide is a piperidine and sulfamoylbenzamide derivative acts as an antidiuretic agent.
Clopamide is indicated for treatment of hypertension.
It is formulated as tablet for oral route of administration.

Mechanism of action:

Clopamide acts at the proximal convoluted tubule site of the nephron where it inhibits the sodium-chloride cotransporter. Clopamide selectively binds at the chloride binding site of the sodium chloride cotransporter in the PCT cells on the luminal side and thus interferes with the reabsorption of NaCl and thus causing an equiosmolar excretion of water along with NaCl.

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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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