GMP manufacturing: Your strategic partner for high-quality pharmaceutical production

Why Kingchem for GMP manufacturing?

• Seamless integration: We offer end-to-end solutions, from process development and optimization to commercial-scale production, all under one roof.
• cGMP expertise: Our Wisconsin facility strictly adheres to current Good Manufacturing Practices (cGMP) as mandated by the U.S. FDA, ensuring the highest quality and compliance for your pharmaceutical products.
• Experienced team: Our seasoned chemists, engineers, and quality assurance professionals have a proven track record of delivering complex projects on time and within budget.
• State-of-the-art facility: Our modern facility boasts advanced equipment and robust quality systems, providing a secure and reliable environment for your GMP manufacturing needs.
• Flexible solutions: We tailor our services to your specific requirements, whether you need small-scale clinical batches or large-scale commercial production.

Our comprehensive GMP manufacturing services

• API synthesis: We synthesize a wide range of high-quality APIs, leveraging our expertise in organic chemistry and advanced technologies.
• Intermediate production: We manufacture critical intermediates with precise control and reliable quality, ensuring a seamless supply chain for your drug development process.
• Excipient formulation: We offer a comprehensive range of excipients and formulation development services to optimize the stability and efficacy of your drug products.
• Analytical testing: Our state-of-the-art laboratory provides comprehensive analytical services, including method development, validation, and stability testing.
• Regulatory support: Our team of regulatory experts ensures your products meet all necessary requirements for successful market entry.

Technical expertise and equipment

Our St. Francis facility is equipped with a wide range of advanced technologies and equipment:

• Diverse reactor systems: We offer reactors ranging from 35L to 6,300L with various materials of construction (glass-lined, stainless steel, Hastelloy) to accommodate your specific process needs.
• Distillation systems: Our fractional and vacuum distillation units with structured packing (20L to 800L) ensure efficient separation and purification.
• Filtration and drying systems: Nutsche filter dryers and other filtration technologies enable seamless solid-liquid separation and drying.
• Analytical instrumentation: Our laboratory houses a comprehensive suite of analytical instruments, including HPLC, GC, NMR, and mass spectrometry.

Quality assurance

We prioritize quality at every stage of the manufacturing process.

FDA Registered: Our St. Francis facility is registered with the U.S. FDA, demonstrating our commitment to regulatory compliance.

• ICH Q7 compliant: Our quality management system strictly adheres to ICH Q7 guidelines for APIs, ensuring the highest quality standards.
• Regularly audited: We undergo routine inspections by the FDA and other regulatory bodies to maintain continuous compliance.
• Certified: We hold FSSC 22000, Kosher, and Halal certifications to meet diverse customer needs.