Custom R&D of pharmaceutical intermediates

Your partner for high-quality, 
cost-effective pharmaceutical intermediates (아피스) 중국에서

  • Stable Supply: stable quality of the product
  • Quality Studies: impurity studies and residual solvent studies in accordance with ICH regulations
  • Documentation Support: support the required process and quality control documentation
  • Price Advantage: process advantage determines our cost advantage
Contact us

As a leading CDMO service provider in China, we can save you a lot of time and financial costs

Relying on our rich experience, 품질 신뢰성 및 공정 안정성, we provide a complete service from product development to product launch.

Why Choose Us

We specialize in the development and production of special chemical structures, such as pyridines, pyrimidines, heterocycles, fluorides, and polymers.

Stable Supply

Our plants are stable because they are located in national or provincial chemical parks. The environmental protection is in full compliance with national requirements, so we do not have the risk of being stopped by goverment at any time, which makes our process very stable and thus makes the quality of our products stable.

Quality Research

We check various starting materials. In terms of impurity research, especially process impurities, residual solvent research, and heavy metal control, we conduct all researches to the extent required by ICH.

Documentation Support

We can cooperate to provide the process and quality control documents required for the declaration, such as synthesis route, process flow chart, impurity list, solvent reagent list, MOA and simple process description.

Price Advantage

Our process advantage determines that we have an absolute price advantage.

Why we can help you save both time and money

Once your project has been identified, our workflow:

Project Establishment

After getting your customized information, we will immediately carry out the following actions: market research, technical evaluation, material inquiry, factory scheduling, and the departments involved will act quickly to organize the project report and implementation plan within 2-3 days.

Project Opening

We set up a project team, consisting mainly of synthesis, analysis and management staff, and then develop a concrete implementation plan.

Process and Quality Research

Open up the route: 첫 번째, purchase a small amount of starting materials and intermediates in the route to open up the route quickly, while establishing a preliminary test method

Process research: We know that advanced intermediates are not only synthesized in the laboratory, but eventually produced industrially.

So we ask the project team to make the process that can be factory produced. Problems that are very easy to occur in the process of lab to plant scale-up production can be solved quickly through our rich experience.

In addition to process research, in the process we will also synthesize (or purchase) impurities quickly, and the starting materials from different suppliers will be strictly verified.

From Lab to Factory

While the process verification is being performed in the laboratory, the materials for the plant are in place and the production documents prepared for the plant are in effect at the same time. The next step is to follow the process protocols for production.

In a poorly managed plant, when a process transfer fails, it is impossible to determine whether the failure is due to the process itself, or operational or equipment problems.

Although the standardization of the plant adds a corresponding cost, the investment is definitely worth it, considering the safety as well as the success rate.

All of our plants are NMPA approved, and we have long-standing, stable relationships with cGMP plants. Our extensive past project experience gives us the confidence to complete each and every process transfer.

Document Organization

When we produce products at the factory, we will have the inspection documents, protocols, and verification documents available at the same time.
The laboratory staff will also prepare the synthesis route, process flow chart, impurity list, solvent and reagent list, MOA, and simple process description, 등.

“최고의 서비스를 제공하기 위해 최선을 다하겠습니다”
Lisa Cho - 영업 관리자

Consult Our Experts For Details

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