We are the right choice when it comes to professional production of active pharmaceutical ingredients and their intermediates. We specialize in the development and production of steroid hormones. We offer the option of customized active ingredient production according to the specific needs of our customers.
After carrying out feasibility studies and adapting our facilities to the specific requirements of each product, we ensure the supply of necessary raw materials in order to guarantee consistent quality. The complex steroid manufacturing processes are backed by modern analytic control and meticulous documentation.
We are in constant communication with our customers to efficiently coordinate all production-related activities.
CHEMICAL /TECHNICAL DEVELOPMENT
- Chemical development of manufacturing processes and syntheses
- Optimization of existing manufacturing processes and syntheses
- Scale-up work
- Analytical development and validation
- Regulatory support
- Synthesis and development of reference standards and working standards
- Synthesis, isolation and characterization of impurities
- Studies of stability
- Photo stability
- Stress test
We offer the technical support necessary to meet the requirements of authorities and customers. This includes the preparation, maintenance and updating of all necessary regulatory documents for:
- Product registration and management in conjunction with the relevant authorities (DMFs)
- Technical packages
- Certificates of compliance with the European Pharmacopoeia (CEPs)
- Hydride-based reduction
- Organometallic reduction