Polisano Pharmaceuticals in facts

70 mil. euro investment

in production and research

70 mil. euro investment

Exporting in +22 countries

around the world

Exporting in +22 countries

>40mil.

commercial units/year

>40mil.

> 95% automation

state-of-the-art equipment

> 95% automation

In Polisano Pharmaceuticals there are 3 manufacturing units projected and built according to GMP standards with the objective of ensuring the technical and technological capabilities to produce a wide variety of pharmaceutical forms – medicines and food supplements.

Out of care for the health of our consumers, Polisano Pharmaceuticals’ manufacturing and control conditions for food supplements are just as strict as those applying to medicines.

General Oral Solid Dosage Forms Production Unit

It is authorized for the manufacturing of tablets, film-coated tablets, lozenges, orodispersable tablets and hard gelatin capsules at GMP standards. The facility has in place industry-leading production and packing equipment as well as quality testing laboratory, adapted to the specific requirements of the production site.

Manufacturing capacity


561 mil. tablets / year

> 49 mil. packets / year

Drugs and supplements general oral solid dosage forms (General OSD)

  • Solid oral dosage forms - tablets, coated tablets, lozenges, orodispersable tablets and hard capsules
  • Granulation line having capacity from 60 Kg to 360 kg with closed transfer product conveying system
  • Blending equipment with single batch bin blending
  • Tableting equipment
  • Filling capsules equipment
  • Coating equipment
  • Packaging lines
  • Laboratory and galenic facilities
  • Warehouse for API, raw & packaging materials and finished products
  • Equipment provided with WIP system
  • All equipment with 21 CFR Part 11 compliance

ONCOLOGY PRODUCTION UNITS


We have launched an extensive investment program and have authorized 2 production lines dedicated to oncology solid oral dosage formulations and oncology injectable products.

Both production lines are equipped with high efficiency and operator protection systems - OEB3 systems and isolator technology

Pharmaceutical forms that will be processed on these production lines:

  • Tablets, film-coated tablets, hard gelatin capsules
  • Injectable solutions in vials 
  • Lyophilized powder in vials
  • Ready-to-use solutions in pre-filled syringes

Manufacturing capacity


227.9 mil. tablets & capsules / year

> 30 mil. packets / year

Oncology Oral Solid Dosage (OSD)

  • Manufacturing with contained granulation processors,
  • Compression machine and Capsule Filling Machine
  • Contained powder transfer systems
  • Capability to handle batch sizes from 5 kg to 36 Kg
  • All major equipment with CIP system
  • Full 21 CFR Part 11 compliance
  • Integrated material identification & management system through ERP
  • Storage facility for materials at Room temperature and Low temperature
  • API sampling & dispensing under Isolator

Injectable Oncology

Compounding

  • Capability to handle batch sizes from 20 L to 75 L 
  • Automated CIP and SIP for compounding vessels and holding vessels
  • Compounding activity through  Isolator technology 
  • Automatic transfer to filling by filtration system 
  • Integrated material identification & management system through ERP (enterprise resource planning)
  • Storage facility for materials at normal conditions (15 – 25°C) and cold temperature (2- 8°C)
  • API sampling and dispensing under isolator condition

Manufacturing capacity


2 mil. Liquid + Lyo injectable vials / year

2 mil. Prefilled syringes (PFS) / year

Total capacity of onco. Injectable = 4 mil. units / year

Filling in vials and PFS and Lyophilization process State of art Isolator technology for the entire filling line with VHP Decontamination

  • Vial Filling / PFS Filling line machines
  • Assembling PFS / stoppering vials machines
  • Particle measuring system for continuous non-viable particle monitoring of isolator
  • All Vial (100%) on-line fill weight check
  • Lyophilization freeze dryers with CIP & SIP
  • External decontamination of vials after capping & sealing

Visual Inspection and Packaging

  • 100% Visual Inspection
  • Automatic machine for optical control of vials
  • Automatic machine for optical control of pre-filled syringes/PFS
  • Labelling machines for vials
  • Blistering & cartooning machines
  • Camera for pharma code verification for label, cartons and inserts (serialization)

Quality Management

The quality system within Polisano Pharmaceuticals ensures to obtain products whose quality corresponds to the purpose for which they were developed, according to GMP standards.

Our approach provides the framework for establishing, implementing and delivering safe and effective products with appropriate quality attributes in order to meet expectations of patients, healthcare professionals, authorities, internal and external clients.

The quality control of raw materials, packaging materials, intermediate and finished products is done through testing and analysis in line with the applicable GMP standards. Polisano Pharmaceuticals owns state-of-the-art laboratories, supervised by skilled and experienced staff.

The quality department ensures that the quality policy is applied in:

  • All the stages of development, production and analytical control
  • Batch release
  • Periodic product quality review