GMP manufacturing St. Francis, Wisconsin, USA
Our FDA-registered GMP facility is your trusted partner for API synthesis, intermediates production, and excipient formulation. We seamlessly scale up from development to commercial production, ensuring the highest quality and compliance with ICH Q7 standards.
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Non-GMP manufacturing Fuxin, Liaoning, China
Our expansive Fuxin facility is your gateway to large-scale production of regulatory starting materials (RSMs), fluorinated intermediates, building blocks, and specialty chemicals. We specialize in complex chemistries, offering tailored solutions for the pharmaceutical industry.
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Global network supporting your success
Beyond manufacturing, our global network ensures comprehensive support for your projects:
Our strategic global network extends beyond manufacturing, providing comprehensive support for your projects at every stage:
- Synergistic operations: Our state-of-the-art facilities work together, making building blocks in China and API in the US to address your unique manufacturing challenges.
- Global logistics & business development (Allendale, New Jersey, USA): Our US headquarters streamlines logistics and ensures seamless communication, connecting your projects with our global resources.
- Global R&D resources: Our R&D teams in Dalian, China and Wisconsin, US can work together to solve your most challenging synthesis and add resources to projects to achieve amazing development breakthroughs on tight timelines.
Quality assurance you can trust
We maintain rigorous quality systems across all our facilities, including:
- FDA registration: Our St. Francis facility is registered with the U.S. FDA and complies with cGMP guidelines.
- ISO certifications: Our Fuxin facility holds ISO 9001 and ISO 14001 certifications, ensuring adherence to stringent quality and environmental standards.
- Regular audits: We consistently pass quality audits from leading pharmaceutical companies, demonstrating our commitment to excellence.
