Kingchem St. Francis, Wisconsin: Your strategic partner for cGMP API development and manufacturing

St. Francis, Wisconsin, USA. Strategically located in the heart of the Midwest, our facility offers convenient access to major transportation routes, ensuring efficient delivery of your products to markets across North America.

Kingchem is committed to uncompromising quality. Our St. Francis facility adheres to:

• cGMP compliance: Rigorous adherence to current Good Manufacturing Practices (cGMP) as mandated by the U.S. FDA.
• ICH Q7 adherence: Our quality management system strictly follows ICH Q7 guidelines for Active Pharmaceutical Ingredients (APIs).
• FDA registration: Our facility is registered with the U.S. FDA, demonstrating our commitment to regulatory compliance.
• Multiple certifications: Our certifications include FSSC 22000, Kosher, and Halal, meeting the diverse needs of our clients.

Our state-of-the-art facility is equipped to support your API needs at every stage, from research and development to commercial-scale production:

• Research & development labs: Dedicated R&D laboratories for process development, optimization, analytical method development and validation, and formulation development.
• Kilo labs: Small-scale production for process optimization and early-stage clinical material generation.
• Pilot plant: Scaled-up production for clinical trials and process validation, facilitating a smooth transition to commercial manufacturing.
• Commercial production: Large-scale production suites for commercial volumes, ensuring consistent quality and reliable supply of your API.

Our state-of-the-art facility is equipped with the latest technologies and infrastructure to address your most demanding API manufacturing needs:

• cGMP manufacturing suites: Purpose-built to meet stringent regulatory requirements, our cleanroom environments ensure the highest quality and safety standards for your APIs.
• Diverse reactor systems (35L – 6,300L): Our versatile reactors, including glass-lined, stainless steel, and Hastelloy options, handle a wide range of reactions and operating conditions, accommodating your specific process needs.
• Advanced distillation capabilities: Our fractional and vacuum distillation units with structured packing (20L – 800L) enable precise separation and purification, ensuring optimal purity and quality of your APIs.
• Efficient filtration and drying: Our advanced filtration and drying equipment, including nutsche filter dryers, facilitate seamless solid-liquid separation and drying processes.
• State-of-the-art analytical laboratory: Our laboratory is equipped with cutting-edge instrumentation (HPLC, GC, NMR, mass spectrometry) for comprehensive analytical testing, method development, validation, and stability studies.

Our facility is designed for efficiency and flexibility, with just under an acre (3,000 m2) of dedicated spaces for research, development, and manufacturing. Our modern, cleanroom environments meet the highest standards of hygiene and safety, ensuring the integrity of your pharmaceutical products.