St. Louis Manufacturing Facility
High-Purity Ingredient manufacturing
Organic synthesis and purification suite
Core Capabilities
- Manufacturing of Active Pharmaceutical Ingredients (APIs) and High-Purity Ingredients (HPIs) such as cGMP excipients and advanced intermediates
- Multi-step organic synthesis, chromatography and crystallization with robust product development
Industry Segments and Applications
- Production chemicals for Pharmaceutical, Biopharmaceutical, and Personal Care markets
- St. Louis also produces injectable Active Pharmaceutical Ingredients (APIs)
Major Products
- Carbohydrates
- Biological buffers
- Excipients
- Active Pharmaceutical Ingredients
Quality Systems
- FDA Registered
- Compliant to ICH Q7, 21CFR 210-211, IPEC
Quality Control Capabilities and Instrumentation
- HPLC
- GC
- UV Spectroscopy
- Endotoxin
- Optical Rotation
- Karl Fisher
- Classical Wet Chemistry
- ICP
Controlled Environment Manufacturing Capabilities
- High-Potency Isolator
- Manufacturing and packaging suites are HEPA filtered (equivalent to ISO Class 6, 7 or 8)
- Closed System Manufacturing