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Sodium salicylate

CAS No.

54-21-7

Reference product

N/A

Polymorphic form

Monoclinic form (space group P21/m)

Therapeutic Area

Alimentary tract & metabolism

Status

commercial

EU DMF readiness

US DMF readiness

026873

Other documentation

Japanese DMF

Drug description

Sodium salicylate is the sodium salt of salicylic acid. It is used as an analgesic and antipyretic.
It is also a potential replacement for aspirin for people sensitive to it.

Mechanism of action:

Sodium salicylate is a non-selective COX inhibitor. It inhibits the two isoforms of cyclooxygenase, COX-1 and COX-2. sodium salicylate irreversibly acetylates cyclooxygenases thereby inhibiting prostaglandin synthesis and associated inflammation and pain.

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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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