St. Francis, Wisconsin USA
GMP intermediates, APIs and excipients
(Kingchem Laboratories, Inc.)
Chemistry Capabilities:
- Acid Chloride Formation
- Aminations
- Anhydrous HCl Handling
- Azeotropic Distillation
- Cycloadditions
- Cryogenic Crystallization
- Cryogenic Reactions
- Elemental Bromine Handling
- Esterification/Hydrolysis
- Friedel-Crafts Chemistries, Vinyl and Aromatic
- Grignard Chemistries
- Heterocycles
- 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 back-end 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 for the plant’s Key Features, Chemistry Capabilities and Site Certifications.
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 Certification
