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Sildenafil citrate

CAS No.

171599-83-0

Reference product

Viagra, Revatio/PFIZER

Polymorphic form

Anhydrous Form 2

Therapeutic Area

Genito-urinary system & sex hormones

Status

commercial

EU DMF readiness

US DMF readiness

023930

CEP

Other documentation

Chinese DMF
Japanese DMF
Canadian DMF

Drug description:

Sildenafil Citrate is an anti-erectile dysfunction agent.
Sildenafil is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil to be effective, sexual stimulation is required.
It is formulated in the form of tablets, film coated tablets and capsules for oral route of administration.

Mechanism of action:

Sildenafil enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil is also an inhibitor of cGMP specific phosphodiesterase type-5 (PDE-5) in the smooth muscle of the pulmonary vasculature, where PDE-5 is responsible for degradation of cGMP. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation in patients with pulmonary arterial hypertension.

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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