Действующие производственные линии

Key sectors	Tablets	Vials/bags	Ampules	Capsules
Scope of localization at POLYSAN production facilities	Full cycle of finished dosage forms manufacturing with capability of performing final stages of API synthesis and purification
Dosage forms	Tablets, including "Oblong" forms, coated and uncoated	Solutions for infusion, for oral use, suspensions for oral use	Solutions for intravenous and intramuscular administration	Hard gelatin capsules
	The dosage form (including tablets’ shape and design) may vary, additional descriptions and specifications must be provided
Maximum production output	700 mln pcs/year	11.5 million units/year - polymer containers	73.5 million units/year	75 mln capsules/year
API requirements	Medicinal products not requiring separate production area in accordance with RF Government Resolution No. 686 of July 6, 2012
Packaging	PVC/Al blister, PVC blister, PVDC/Al blister, Al/Al blister (descriptions of blister requirements must be provided)	Polymer containers of polyester film with one or two SFC ports, available in 5000 ml, 1000 ml, 500 ml, 250 ml, and 100 ml volumes. Сolor container labeling is possible.	Ampules of 1 ml, 2 ml, 5 ml, 10 ml, 20 ml volume	PVC/Al, Al/Al blisters
	Possibility to apply labeling for serialization and aggregation purposes in accordance with Government resolution No. 62 of January 24, 2017. Possibility to apply a tamper-evident label to secondary packaging.
Sterilization requirements	—	1. Production of medicinal products with terminal sterilization 2. Technical possibility for organizing aseptic production of medicinal products in ampoules available	—
Storage conditions	No cold chain is required
Specific requirements	POLYSAN manufacturing lines do not produce cytostatics (operations with API with an OEB class NMT 3, toxicity class NMT 3 in accordance with GOST 32419-2013), no processes emitting significant quantities of dust, vapors and gases, as well as processes involving explosive substances are available
Occupational safety requirements	API ОЕВ NMT 3
Equipment cleaning requirements	Cleaning of existing production lines is performed within standard equipment cleaning procedures using CIP/SIP or WIP stations, detergents approved for pharmaceutical industry (alkaline, acidic) processes
Excipients requirements		For existing production lines: oils or ethyl alcohol in composition are not allowed
Waste disposal	3-5 hazard class waste

Key sectors

Tablets

Vials/bags

Ampules

Capsules

Scope of localization at POLYSAN production facilities

Full cycle of finished dosage forms manufacturing with capability of performing final stages of API synthesis and purification

Dosage forms

Tablets, including "Oblong" forms, coated and uncoated

Solutions for infusion, for oral use, suspensions for oral use

Solutions for intravenous and intramuscular administration

Hard gelatin capsules

The dosage form (including tablets’ shape and design) may vary, additional descriptions and specifications must be provided

Maximum production output

700 mln pcs/year

11.5 million units/year - polymer containers

73.5 million units/year

75 mln capsules/year

API requirements

Medicinal products not requiring separate production area in accordance with RF Government Resolution No. 686 of July 6, 2012

Packaging

PVC/Al blister, PVC blister, PVDC/Al blister, Al/Al blister (descriptions of blister requirements must be provided)

Polymer containers of polyester film with one or two SFC ports, available in 5000 ml, 1000 ml, 500 ml, 250 ml, and 100 ml volumes. Сolor container labeling is possible.

Ampules of 1 ml, 2 ml, 5 ml, 10 ml, 20 ml volume

PVC/Al, Al/Al blisters

Possibility to apply labeling for serialization and aggregation purposes in accordance with Government resolution No. 62 of January 24, 2017. Possibility to apply a tamper-evident label to secondary packaging.

Sterilization requirements

—

1. Production of medicinal products with terminal sterilization
2. Technical possibility for organizing aseptic production of medicinal products in ampoules available

—

Storage conditions

No cold chain is required

Specific requirements

POLYSAN manufacturing lines do not produce cytostatics (operations with API with an OEB class NMT 3, toxicity class NMT 3 in accordance with GOST 32419-2013), no processes emitting significant quantities of dust, vapors and gases, as well as processes involving explosive substances are available

Occupational safety requirements

API ОЕВ NMT 3

Equipment cleaning requirements

Cleaning of existing production lines is performed within standard equipment cleaning procedures using CIP/SIP or WIP stations, detergents approved for pharmaceutical industry (alkaline, acidic) processes

Excipients requirements

For existing production lines: oils or ethyl alcohol in composition are not allowed

Waste disposal

3-5 hazard class waste