CMO_Contract Pharmaceutical Laboratory – Laboratorium SANITATIS,

products

• Human medicines.
• Medical devices.
• Food supplements.
• Cosmetics.
• Veterinary medicines

Manufacturing of Batches for Clinical Trials

• Importation of active substances and medicines.
• Manufacturing of placebos, medicines, food supplements.
• Design of blinding strategy.
• Labelling for primary and secondary packaging.
• Storage Good Manufaturing Practices (GMP) conditions.
• Shipping management to the different centers.
• Return, reconciliation and destruction of medicines.

Pilot Batches and Registration Batches

• Manufacture in compliance with the principles and guidelines of GMP for medicinal products.
• Transfer of analytical techniques

Contract Manufacturing of Industrial Batches for Third Parties 

• Quality control and certification of active substances, excipients and finished products.
• Manufacturing in GMP conditions.
• Validation of cleaning processes.
• Analysis and batch release.
• Storage in GMP conditions.

Industrial Scale 

• Scaling up from laboratory batches to industrial batches.
• Validation of new manufacturing and packaging processes.

AUTHORIZED DOSAGE FORMS

• Solids (tablets, coated tablets, capsules, etc.).
• Liquids (solutions, syrups, drops...).
• Semi-solids (creams, emulsions, gels, etc.).

equipment

• Mixing: Rulon, V, Vima Cyclops.
• Granulation: High Speed, Oscillating.
• Drying: Static, Fluid Bed.
• Capsules filling: Manual, Macofar CD-40.
• Tabletting machine: Kilian.
• Tablet coating: IMA-70 drum coating.
• Liquids: 100L, 2.400L reactors.
• Semisolids: 10L, 300L, Mixer.
• 1st Packaging:
  • Tube: Alu, PE.
  • Bottles: glass, PET.
  • Blister packing machine ALU/ALU PVC/ALU.
• 2nd Packaging:
  • Cartoner.
  • Labeling.

ACREDITATIONS AND RECOGNITIONS

• ISO 9001
• Good Manufacturing Practices (GMP) - Pharmaceutical development and manufacturing.
• Good Laboratory Practices (GLP) - Pharmaceutical development.
• Spanish Medicines Agency (AEMPS) inspection with positive result - Clinical trials and Bioanalysis.
• We work under Good Clinical Practices (GCP) - Clinical Trials Unit.

Access to our Acreditations and Recognitions