SK pharmteco is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities.
With over 75 years of experience in mastering challenging chemistries, we have developed capabilities that support a wide range of processes and technologies. Our facility has over 158,000 gallons (598 m³) of manufacturing capacity and is capable of handling all scales of production. Our products are manufactured in full compliance with the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP).
Our Specialties:
- Energetic Chemistries
- High Potency APIs (HPAPIs)
- Chromatographic Separations (SMB)
- Continuous Processing
- U.S. DEA Controlled Substances (Schedule II-V)
- Specialized Chemical Capabilities
- Process R&D Supports Products at all Phases of Development
- New Route Development
- Process Development to Generate Commercially Viable Route
- Technical Transfer of Existing Route and Process
- Detailed Process Design, Including DOE, to Support Validation Activities
- Production of Intermediates and API to Support Clinical Trials
- Continued Optimization of Commercial Processes
- Full Process Safety Assessment
- Analytical Method Development Services to Support all Development and Scale-up Activities
- Identification and Assessment of Cost Effective and Reliable Raw Material Suppliers
