Laboratorium Sanitatis by TECNALIA is authorised by AEMPS as a manufacturer and importer of pharmaceuticals and drugs under research, with Registry Number 4163E and Certificate of GMPs.
We have unique facilities with extensive scale-up and manufacturing possibilities for drugs, medical devices and cosmetics, within the strictest environment with regard to applying and meeting GMPs.
Location
Description
We have gained the trust of large companies in the pharmaceutical sector due to our reliability, competitiveness and experience.
Products:
- Drugs for human and veterinary use
- Medical devices
- Food supplements
- Cosmetics
Manufacture of batches for clinical trials:
- Importation
- Manufacture of placebos and drugs
- Design of masking strategies
- Labelling for primary and secondary conditioning
- Storage
- Dispatch management
- Return, reconciliation and destruction of drugs
Manufacture of pilot and registration batches:
- Manufacturing
- Transfer of analytical techniques
Manufacture of industrial batches for third parties:
- Quality control: analytical certificates for APIs, excipients and finished products
- Manufacture and validation of cleaning processes
- Analysis and release of batches
- Storage
Industrial manufacturing:
- Adaptation of batch sizes to an industrial scale
- Validation of new processes
Pharmaceutical forms:
- Solids
- Liquids
- Semi-solids
Equipment:
- Mixers: Rulon, V, Cyclops Vima
- Granulation: high-speed, oscillating
- Drying: static, fluidised bed
- Capsule fillers: manual, Macofar CD-40
- Tablet presses: Kilian
- Coated tablets: IMA-70 coating drum
- Liquids: 100 l, 2,400 l reactors
- Semi-solids: 10 l, 300 l mixer
- Ac 1:
- Tubes: Alu, PE
- Bottles: glass, PET
- Blister packing machine
- Ac 2:
- ALU/ALU and PVC/ALU blister packaging machine
- Box-making machine
- Labelling machine
Aimed at:
- Pharmaceutical laboratories that want a partner to manufacture their drugs.
Certifications and Recognitions
The Pharmaceutical Development Control Laboratory is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Physical and chemical quality control medicines for human use and medicines under research.
The manufacturing plant is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Manufacture and import of pharmaceuticals for non-sterile human use, including psychotropic and narcotic substances / Manufacture and import of non-sterile investigational medicinal products.
The drug manufacturing plant has been granted the ISO 13485 certification for quality management for the medical devices industry.
