Pharmaceutical intermediates provide the pharmacological action required for a drug. To make sure that prospective novel therapies are secure, efficient to create, and safe, pharmaceutical intermediates that exhibit promise in the early phases of drug development must go through a rigorous testing and research process. To enable long-term manufacturing, customers require the know-how to create and improve reliable, transferable, and scalable processes.
From technical and analytical transfer to process optimization and validation, we can apply our extensive process development experience to your APIs. Our company offers a full range of CDMO services for your pharmaceutical intermediates, with a focus on quality, speed, and flexibility.
Service Overview
Pharmaceutical intermediates are some chemical raw materials or chemical products used in the process of drug synthesis, which can successfully support the process development of both novel pharmaceuticals and generic drugs. Some of these key intermediates may also be the key factor that restricts the process development. For the manufacture of the first gram of a small molecule up to a few kilograms, Our company provides a full spectrum of early process development and scale-up services.
In accordance with ICH and NMPA laws and recommendations, we can offer our customers a full range of services, including the creation of manufacturing processes for drug intermediates, optimization for commercial production, and registration files. We can combine innovative synthesis and purification to design more efficient processes that add value and increase throughput.
The following are our synthesis technologies for pharmaceutical intermediates.
- Directional nitrification technology
- Condensation technology
- Controlled oxidation technology
- Fluorination technology
- Hydrogenation reduction technology
- Asymmetric synthesis
- High-temperature and high-pressure reaction techniques
- Asymmetric catalytic reactions such as biocatalysis
Research Capabilities
Our company's pharmaceutical intermediates R&D capabilities are as follows.
- Capability of structural analysis and performance testing of pharmaceutical intermediates.
- Introduction, design and research of product technologies for pharmaceutical intermediates.
- Development and optimization of commercial processes through design of reaction and quality by design.
- Unit operation studies and identification of key process parameters for each step.
- Study of impurity structure, source, and control.
- Definition of starting materials.
- Screening of commercialization routes.
- Rapidly obtain the results of pharmaceutical intermediates in small trials and undertake pilotscale-upp tasks to provide a reliable process basis for industrial production.
Overall Solutions
| Project Name | Pharmaceutical Intermediate Development Service |
| Service Details | - Design of synthetic routes for intermediates with intellectual property and cost advantages.
- Process route screening, optimization of the process, quality studies, and process safety assessment.
- Scale-up production.
- Development and validation of analytical methods.
- Provide synthesis route development, process optimization, and scale-up production services for fine chemicals, especially for some high-value-added fine chemicals.
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| Deliverables | Original images and raw data.
A complete experimental report, including experimental materials, experimental procedures, and experimental results. |
| Cycle | Decide according to your needs. |
If you want to know more about service details, please feel free to contact us.
Related Services
It should be noted that our service is only used for research, not for clinical use.
