Intermediates

Pharmaceutical intermediates are chemical raw materials or products used in the pharmaceutical synthesis process. They effectively promote the R&D process of new and generic drugs, and some key intermediates may also become critical factors restricting process development. In compliance with the regulations and guiding principles of the ICH and NMPA/FDA, our CMC Department can provide clients with integrated pharmaceutical services, including the development of pharmaceutical intermediate production processes and the optimization of commercial production, as well as all registrations and filings.

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Service we provide

Medicilon’s services regarding intermediates or other chemical-related businesses
Intermediate synthesis route featuring intellectual property and cost advantagesRoute selection, process optimization, quality research, and process safety evaluation Scale-up production (GMP or non-GMP) Development and validation of analytical methodsSynthetic route development, process optimization, and scale-up production for fine chemicals, especially the process development and production of some high value-added fine chemicals

Pharmaceutical intermediates synthesis technology
Directional nitrificationHigh-temperature and high-pressure reaction Condensation Controlled oxidation Fluorination Hydrogenation reduction Asymmetric synthesisAsymmetric catalytic reactions (such as biocatalysis)

Medicilon’s pharmaceutical intermediates R&D
The introduction, design and research of pharmaceutical intermediate productsSelection of commercial routesDevelopment and optimization of commercial processes, based on design of experiment (DoE) and quality by design (QbD)Research on unit operations and determination of key step-by-step process parametersResearch on the structure, source and control of impurities Determination of initial materials, based on GMP Timely procurement of laboratory-scale test results of pharmaceutical intermediates and pilot-scale testing so to provide a reliable technological basis for industrial productionStructural analysis and performance testing of pharmaceutical intermediates

Technical Platform:

Safety Assessment Lab Of Process Chemistry

During the synthesis process to the scale up process in the laboratory, errors and risks must be controlled. In the development of innovative drugs, the assessment of the safety of chemical processes and equipment is extremely important.

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Process Department Solid Form Screening Platform

The solid screening platform of Medicilon process department strictly complies with the regulations and regulatory requirements of the NMPA, FDA and other regulatory authorities.

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Relevant laboratories