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Xylometazoline hydrochloride

CAS No.

1218-35-5

Reference product

OTRIVIN/GSK

Polymorphic form

Therapeutic Area

Respiratory system

Status

commercial

EU DMF readiness

CEP

Drug description:

Xylometazoline is a nasal vasoconstricting decongestant drug.
It is indicated for the temporarily relieves nasal congestion due to cold, hay fever or other respiratory allergies. It is indicated in treatment of acute allergic rhinitis, sinusitis, pollinosis, otitis media (to reduce edema of the nasopharyngeal mucosa).
It is formulated as spray for nasal route of administration.

Mechanism of action:

Xylometazoline is a direct acting sympathomimetic adrenergic alpha-agonist.
It induces systemic vasoconstriction, thereby decreasing nasal congestion. The sympathomimetic action of xylometazoline constricts the smaller arterioles of the nasal passages, producing a prolonged decongesting effect.

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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
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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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