It is possible to establish a brand-new production line based on the customer requirements and to produce various dosage forms within 1800 m2 GxP-compliant production area.
Localization at POLYSAN sites | Full production cycle for finished dosage forms and the possibility of final synthesis and API treatment stages |
Dosage forms |
Unlimited possibilities for establishing the production line |
Max. production capacities |
Subject to further discussion |
API requirements | It is possible to manufacture DP that require a dedicated area according to RU Governmental Decree No. 686 as of July 06, 2012 (except for penicillin and cephalosporin DP) |
Packaging |
Unlimited possibilities for establishing the production line |
Sterilization requirements |
Unlimited possibilities for establishing the production line |
Storage conditions |
No cold chain |
Occupational safety requirements |
API OEB – not higher than 4 | Equipment cleaning requirements |
Unlimited possibilities for establishing the production line |
Requirements to components |
No particular requirements to the composition |
Waste disposal |
Wastes of 3-5 hazard categories |