POLISINTEZ Ltd. is a Russian manufacturer of APIs. Subsidiary of “STPF POLYSAN” Ltd.


Полисинтез - лекарства зарождаются у нас

POLISINTEZ Ltd. focuses on small and medium-scale production of APIs. The company implements process flows for sterile and non-sterile product dosage forms, involving full-cycle operation (from chemical synthesis to finished product supply to warehouse).

FULL CYCLE OF API DEVELOPMENT

Таймлайн
01.
Laboratory development (from 50 ml to 2 liters)
02.
Testing of Technology at R&D site (5-10 liter reactors)
03.
Transfer to pilot production site (160 liter reactors)
04.
Technology transfer to existing production (10-4000 liter reactors)

QUALITY

“Polisintez” Ltd. ranks among TOP-5 Russian companies manufacturing and developing active pharmaceutical ingredients. The company complies with all mandatory EAEU GMP regulations.

EAEU GMP regulations
polisintez

OUR COMMITMENTS

We ensure compliance with all mandatory EAEU GMP regulations.
We are goverened by ICH, ISPE, and ISO 9001 standards.

OUR CAPABILITIES

We have own licensed microbiological testing laboratory.

Licenses and Certificates
We continuously control semi-finished products at every site 24/7 (including HPLC and GLC analysis).
All analytical tests, except for "Abnormal Toxicity" are performed at our own facility.

POLISINTEZ API PRODUCTION

Polisinthez actively participates in the Russian Ministry of Industry and Trade's Project on traceability of pharmaceutical raw materials/API.

POLISINTEZ PLANT PHOTO GALLERY

01_API technology.jpg
Development department. Design of new API technology
02_HPLC method.jpg
Product control using HPLC method
03_Bacterial.jpg
Bacterial endotoxin level control
04_API.jpg
Development department. Design of new API technology
05_Quality Control.jpg
Development department. Development of Quality Control methods
06_new line.jpg
API packaging on a new line
07_API production.jpg
New lines for final stages of API production
08_Process monitoring.jpg
Process monitoring. New process flow for small-scale API production
09_R&D area.jpg
R&D area. Technology scaling-up
10_Small-scale process.jpg
Centrifuge (wet semi-finished product manufacturing stage). Small-scale process flow
11_ N-methylglucamine.jpg
Centrifuge (wet semi-finished product manufacturing stage). N-methylglucamine process flow
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