We provide professional Contract Development and Manufacturing Services (CDMO) for small molecule Active Pharmaceutical Ingredients (APIs), offering comprehensive support to pharmaceutical companies from R&D to large-scale production. Our services cover the synthesis, process optimization, scale-up production, quality control, and regulatory filing of small molecule APIs, ensuring that products meet GMP and international quality standards.
Core Services:
Small Molecule API R&D and Synthesis: We offer customized R&D and synthesis route design for small molecule APIs, optimizing processes to enhance yield and purity.
Process Scale-Up and Production: We efficiently support the scale-up of processes from laboratory to commercial production, ensuring consistent quality.
Quality Assurance and Compliance: We ensure products meet GMP requirements, providing full-scale quality control and stability testing.
Regulatory Support: We assist with the preparation of regulatory filing documents, helping clients successfully obtain drug approvals in global markets.
Through our professional CDMO services, clients can accelerate product development, reduce production costs, and achieve efficient and compliant market access.