CONTRACT MANUFACTURING POSSIBILITIES:
- procurement of raw materials
- manufacture of bulk products
- confection and packaging
- stability studies
- quality control and product release for sales
AVAILABLE PHARMACEUTICAL FORMS:
- Solid forms of drugs (capsules, tablets, coated tablets, powders) including penicillin forms
- Sterile forms of drugs (sterile powders and lyophilized powders for injection) including penicillin forms
- Dermatological forms of drugs (gels and aerosols)
FORMS OF PACKAGING:
- Bottles (oral suspensions)
- Blisters ALU /ALU; ALU/PCV; ALU / PVDC (capsule, tablets)
- Tubes (gels)
- Containers (pressure aerosols)
- Insulin cartridges
Modern production facilities and maintaining production processes in accordance with international standards guarantee quality of manufacturing. The integrated nature of our business allows us to offer production of finished formulations, active pharmaceutical ingredients and laboratory services.
Polfa Tarchomin S.A. provides contract manufacturing services. At present our offer in this field includes:
- Preparation of concentrates and filling and packaging of aerosols into monoblock aluminium cans type A (diameter 35mm) with a capacity of 50 ml and 80 ml;
- Preparation and filling and packaging of gels for aluminum tubes 15 g, 30 g, 50 g;
- Production of solution and suspension containing human insulin in 3 ml cartridges for injection pens;
- Production of solid oral penicillin forms including mixing, granulation (dry & wet method), compaction, tableting, coating (water, sugar and organic solvent coating) or encapsulation (capsules No. 0,1,2,3) and packaging into blisters Alu/PVC or Alu/Alu;
- Preparation of penicillin injectable forms (washing, sterilization, aseptic powder filing, closing and packaging of 20 ml vials into carton boxes);
- Production of penicillin powders for oral suspension in bottle of 35 ml, 70 ml, 140 ml;
- Production of solid oral non-penicillin and non-cephalosporin forms including mixing, granulation (dry & wet method), tableting, coating (water, organic solvent coating) or encapsulation (capsules No. 00, 0,1,2,3) and packaging into blisters Alu/PVC, Alu/PVDC and containers;
- Filling of powders or granules containing non-penicillin or non-cephalosporin antibiotics for 30 - 200 ml bottles.
Our production areas meet global standards ensuring an adequate and stable quality of medicinal products. We also offer other services related to pharmaceutical production, such as release of production batches, storage services.
Polfa Tarchomin S.A. possesses new facility dedicated for synthesis of active pharmaceutical ingredients
The facility possesses 3 technological lines for the synthesis of various products including antibiotics. The following operations can be performed on installations: synthesis at -10 ÷ 1100C, crystallization at: -10 ÷ 800C, vacuum and pressure filtration, vacuum distillation, vacuum drying at temperature up to 800C, grinding, micronisation and ultrafiltration.
- The minimum batch size: 5kg
- The maximum batch size: 50 kg
The existing conditions allow for different synthesis processes in a wide range of pH, pressure, including the Ex area and sterile conditions (Class B).
Polfa Tarchomin S.A. provides service of decreasing size of particles of various APIs groups in compliance with cGMP rules. The micronisation process is conducted by grinding and milling in air-jet mills. For sensitive solid materials particle size reduction can be performed in a nitrogen atmosphere.
The micronisation results are checked by applying a laser and microscopic methods.
Production capacity approx. 2000 kg annually.
Polfa Tarchomin S.A. provides comprehensive microbiological, physicochemical and pharmacological research and environmental monitoring in the manufacturing of medicinal products.
The Analytical Department offers its services in the field of:
- assessment of sterility of medicinal products,
- assessment of microbiological purity of raw materials, active ingredients, packaging and medicinal products
- determination of biological activity of active ingredients and antibiotic medicinal products
- determination of consistency of content of the active ingredient in antibiotic medicinal products.