VÝROBA API
Our team of experts can provide for you:
- Process development and manufacture of APIs according to cGMP standards
- Production of laboratory batches and scale up small productions
- Validation of laboratory batches. It includes process and purification validation.
- The expertise and capability to establish the Drug Master File for your API
- Compilation of registration dossiers
Technical Capabilities
- Common organic reactions (temperature ranging from -20 °C to +135 °C, pressure up to 6 bar)
- Stainless steel batch reactors from 400 to 1600 liters
- Glass-line batch reactors from 50 to 3800 liters
- Glass batch reactors from 1 to 1000 liters
- Dedicated and multipurpose production lines
- Molecular distillation up to 5 Pa
- Kilo-lab
- Filling line for liquids (30ml – 1000ml) operating in clean room D
- HVAC systems (clean room class D), PW systems (PhEur)
Standard Operations
- Epimerization of sugars
- Additive-elimination reaction
- Substitute nucleophilicand electrophilic reaction
- N-alkylation
- Reduction of ketones and carboxylic acids with hydrazine
- Heterocycle formation
- Esterification
- Hydrolysis
- Peptide bond formation
- Ion-exchange
- Methylation (etherification)
- Organic salt formation
- Bromination