API Production
Narcotic Products Capabilities:
- Morphine based narcotic API’s
- Thebaine based narcotic API’s
- Synthetic based narcotic API’s
- Backwardly integrated poppy straw
- 10 narcotic API’s backed by CEP’s
- Ability to handle control drugs through supply chain
- Fully integrated supply chain can take your product from farm to pharmacy
- Global supply
API R&D
- Optimising of a selected synthetic route
- Analytical method development
- Evaluating scale-up and safety
- Producing pilot batches
- Preparing validations including cleaning validations
- Producing pre-validation and validation batches
- Continuous improvement of technologies and processes
- Stability testing at all stages
- Risk analysis, REACH agenda
- Synthesising and characterising impurities
- Compilation of registration documentation CEP, DMF
API Production Capabilities
- Multi purpose commercial production facilities
- Pilot plant & cGMP Kilolab
- Total reactor capacity of 190m³
- Broad range of production technologies and chemical expertise
- 141 glass-lined and stainless steel vessels ranging from 60 to 6.000 liters
- Batch size: approx. 0,5 to 700 kg/batch
- Milling and micronization equipment
- QC testing
- Controlled substance license
- Human API and Veterinary API EU GMP
API Production Technologies
- Catalytic processes
- Separation solid-liquid
- Separation liquid-liquid
- Absorption
- Adsorption
- Distillation, rectification
- Crystallization
- Drying
- Particle size modification
- Recycling of solvents
- Extraction and Isolation from natural MT raw material