Supply of Non-GMP API

Our company offers non-GMP API supply services, focusing on efficient and flexible active pharmaceutical ingredient (API) production for early-stage research, preclinical studies, and small-scale projects. With state-of-the-art laboratory facilities and diverse synthetic capabilities, we are able to respond quickly to customer needs, providing high-quality APIs. The non-GMP production process is streamlined, reducing delivery timelines while ensuring the purity and performance of compounds. Leveraging our extensive technical expertise and reliable supply chain management, we provide competitive, customized solutions to pharmaceutical companies and research institutions, supporting their development processes.

Contract Manufacturing Services

Small-Scale Production: Provide non-GMP APIs for clients requiring small-scale production, supporting internal R&D and trial production.
Technology Transfer Support: Supply necessary non-GMP APIs during technology transfer processes, facilitating a smooth transition to GMP production.
Preclinical Studies

Pharmacodynamics and Toxicology Studies: Conduct in vivo and in vitro pharmacodynamics studies and evaluate effective dosage ranges.
Pharmacokinetic Studies: Use pharmacokinetic data to establish mathematical models, predicting the behavior of drugs in the body, aiding in the design of appropriate dosing regimens and adjustments.
Flexible Non-GMP Production Facilities

Custom Production Lines: Adjust production line configurations according to different project requirements, flexibly addressing various synthetic challenges.
Streamlined Process Control: As non-GMP production is not subject to the full regulatory requirements of GMP, we can streamline processes, shortening production and delivery cycles while ensuring basic product quality.
Rapid Transition: Capable of quickly transitioning from one project to another, reducing downtime between projects and enhancing production efficiency.
Standards and Reference Materials

Quality Control Standards: Provide standards for laboratory quality control, ensuring reliability of experimental data.
Method Validation: Supply reference materials for method development and validation, ensuring accuracy and reproducibility of analytical methods.
Custom Synthesis Services

Specialty Chemicals: Synthesize specific non-GMP APIs according to client requirements to meet personalized research and development needs.
Complex Synthesis: Provide APIs for projects requiring complex chemical synthesis, supporting highly specialized R&D needs.
Pilot Scale and Process Scale-Up

Pilot Production: Supply APIs for the pilot phase to verify the feasibility and stability of production processes.
Process Development: Support small-scale production and optimization during process development, supplying necessary APIs for process validation and refinement.
Research and Development Phase

Chemical Drug Development: Supply APIs for chemical drug synthesis and testing, aiding pharmaceutical companies in early-stage drug development and laboratory research.
Biopharmaceutical Development: Provide key intermediates and APIs for the development of biopharmaceuticals, supporting early experimental and development efforts.