St. Francis, Wisconsin USA
GMP intermediates, APIs and excipients
(Kingchem Laboratories, Inc.)
- Acid Chloride Formation
- Anhydrous HCl Handling
- Azeotropic Distillation
- Cryogenic Crystallization
- Cryogenic Reactions
- Elemental Bromine Handling
- Friedel-Crafts Chemistries, Vinyl and Aromatic
- Grignard Chemistries
- Hydride Reductions
- Lewis acid catalysis
- Lithiation Chemistries
- Oxidation Chemistries
- Reformatsky Chemistries
- Reduction Chemistries
- Solid Form Manipulation
- Steam Distillation
- Transfer Hydrogenation
- Transition metal catalyzed coupling reactions
Our Wisconsin (USA) facility, Kingchem Laboratories Inc., offers full cGMP production for GMP intermediates, APIs and excipients, and can include the upstream integration of RSMs available through our plant in China.
Kingchem Laboratories has an experienced team that can engage at every phase of drug development, from pre-clinical through commercialization. The production assets at KLI range from pilot plant to full commercial scale and include a variety of materials of construction including glass-lined, stainless steel, and Hastelloy. See below and to the left for our plant’s Key Features, Site Certifications and Chemistry Capabilities.
Key features include:
- cGMP: FDA registered for GMP manufacturing of pharmaceuticals (APIs, pharmaceutical intermediates, excipients).
- Experienced Staff: Key staff with 10-30 years in GMP manufacturing from CDMO to large pharma.
- Facility Footprint: 33,000 sq. ft.
- Reactor Volume Range: 35-6,300 L
- Reactor Temperature Range: -78°C to 160°C
- Reactor MOC: Stainless Steel, Glass-lined, Hastelloy
- Pressure: Up to 6 bar (90 psi)
- Distillation Capabilities: 20 L – 800 L, 20°C to 250°C (hot oil), <1 mmHg, 5-10 theoretical plates
Production Site Certifications
- FDA Drug Establishment Registration
- State of WI, Dept. Safety and Prof. Services – Pharmaceutical Manufacture
- Food Processing Plant (Facility Identifier: 12671692120)
- Kosher Certification (Chicago Rabbinical Council)
- Halal Facility Certification (Islamic Services of America)
- CTPAT certified