Capability to develop medicinal products not registered in the Russian Federation for the purpose of further local product manufacturing

PRODUCTION OF VARIOUS DOSAGE PHARMACEUTICAL PRODUCTS AT 1,800 M2 PRODUCTION AREA COMPLYING WITH GXP REQUIREMENTS

Scope of localization at POLYSAN production facilities Full cycle of finished dosage forms production with capability of performing final stages of API synthesis and purification
Dosage forms Production line capabilities are not limited
Maximum production output To be discussed with the Client
API Requirements Capability to manufacture pharmaceutical products requiring separate production area in accordance with RF Government Resolution No. 686 as of 06.07.2012 (exception: penicillin and cephalosporin drug products)
Sterilization requirements Production line capabilities are not limited
Storage conditions No cold chain is required
Occupational safety requirements API not higher than 4
Equipment cleaning requirements Production line capabilities are not limited
Excipients requirements No specific requirements to composition
Excipients requirements No specific requirements to components
Waste disposal 3-5 hazard class waste

CONTRACT MANUFACTURING
OF FINISHED DOSAGE FORMS AND API, CDMO

Contact us in any way convenient for you:

Свяжитесь с нами

tel.: +7 (812) 448-22-22
e-mail: info@polysan.ru

Polysan

Contacts

192102, Russia, Saint Petersburg,
Salova St., 72, Bldg. 2, Lit. A.

+ 7 812 448-22-22 info@polysan.ru

Pharmacovigilance

192102, Russia, Saint Petersburg,
Salova St., 72, Bldg. 2, Lit. A.
Pharmacovigilance group
of the Medical Department.

+ 7 812 448-22-22 safety@polysan.ru