Services

One-stop service from basic biomedical research and drug discovery to large-scale production of APIs and pharmaceutical intermediates

Chemexpress is committed to creating a drug research and development service platform integrating CRO/CMC/CDMO of high-end APIs, providing products and technical services covering drug discovery, preclinical study, clinical study and industrialization.
Chemexpress uses an R&D system and platform established in the development of building blocks and reference compounds to provide customers with R&D services of CRO technology in the forms of FTE and FFS. Taking customers’ needs for APIs and intermediates into consideration, the company offers process development of innovative or generic drugs and relevant CDMO services, such as small-batch preparation, process optimization, scale-up production, registration and validation of batch production, and commercial production. Furthermore, during registration application phases of IND and ANDA, Chemexpress provides domestic and foreign pharmaceutical companies with CMC services for the application such as API process research, quality research, stability study and application dossiers writing.
The company has a self-developed enterprise resource planning system to meet the needs of high-level information. We have integrated system management of large-scale compound sample libraries to provide customers with efficient services. We have an effective management system for the entire process such as product investigation, research and development management, quality control, customer management, order management, logistics management and financial management.
Service Advantages
Technology platform management First-class R&D team Advanced R&D equipment Strict quality control Continuously improving management system

Customized Synthesis Services

Chemexpress possesses a high-level R&D team with more than ten years of rich experience. They can quickly design and optimize synthetic routes, and provide customized R&D services for products with the size ranging from milligram to kilogram. We provide a technology platform and advanced technical reserves in the field of customized synthesis, and professional support from quality control and customer service teams. We are widely recognized by customers ranging from pharmaceutical companies, research institutes and universities, etc. Seamless customer interface, efficient communication and fulfilling mission are our consistent goals.

Customized synthesis of building blocks

Customized synthesis of reference compounds and compound libraries

Customized synthesis of APIs and intermediates

Customized synthesis of impurity controls

Customized synthesis of special chemicals

Process R&D Services

Chemexpress has excellent technical research and development strength and has been committed to the process of innovation, research and development for many years. With profound professional accumulation in the pharmaceutical industry, as well as advanced technology research and development systems and standardized service management systems, we can provide customers with one-stop service from pre-clinical to commercial. Thanks to the support from our professional synthesis, QC, QA and registration teams, we can make an immediate response and provide efficient service to meet our customers' different demands on process research and development.

Commissioned development of innovative process routes for compounds

We will carry out new route screening and optimization based on customers' requirements as set in the innovation targets until all the established needs are met.

Commissioned development of designated routes for compounds

We will conduct route development and optimization according to the specific routes designated by customers until all the established needs are met.

Existing process route optimization for compounds

We will perform route optimization by referring to customers' existing process routes until their established needs are met.

Commissioned development and screening of crystal form and salt type of compounds

We will carry out screening according to customers' specific requirements for crystal form and salt type of compounds until the established needs are met.

APIs and Intermediates Production Services

Our R&D team follows the concept of QbD , We plan from a design perspective and use our own or outsourced production resources for various specifications and systems to provide customized and commissioned production of APIs or intermediates. Especially in the field of high-potency API research, the company is equipped with a series of advanced devices and instruments. Currently, we have completed the development of several series of highly active API or intermediate products. Our R&D team has rich experience. Moreover, both the GMP-like laboratory in Shanghai R&D Center and the GMP laboratory in Maanshan R&D Center can effectively support the development, production and registration of high-potency drug intermediates and API products to meet R&D and production needs of different partners.

  • Commissioned production of marketed APIs or intermediates
  • Commissioned development and production of innovative APIs or intermediates
  • Commissioned development and production of high-potency APIs or intermediates

Quality Research & Registration Application Services

The company has a professional analysis and quality research team and an experienced registration application service team, which provides comprehensive services ranging from pre-clinical to commercialization, from new drugs to generic drugs. Our teams use a standardized management system to ensure the authenticity and professionalism of the dossiers and assist the drug regulatory authorities in the inspection. We are highly efficient in providing drug registration application services to meet regulatory requirements for domestic and foreign customers. Currently, the company has completed many successful cases in the field of registration application services.

Quality research of APIs and intermediates

Equipped with NMR, HPLC, GC, LC-MS, XRPD, DSC, TGA, PSD, PLM and other instruments and devices
The professional quality research team, with years of experience

CMC, clinical registration studies and application dossiers writing of APIs

Route screening & process optimization of APIs
Quality research and stability study of APIs
Screening research of crystal form and salt type of APIs
Preparation of samples for clinical application and clinical study
Application dossiers writing, on-site inspection accepted
Development and stable supply of starting intermediates of APIs

ANDA, production application research and application dossiers writing of APIs

Designing and optimization innovative API routes, avoiding risks of patent infringement.
Assist in launching the design of new crystal forms of APIs in advance to avoid patent infringement
Complete quality research of APIs
Application dossiers writing, on-site inspection assistance
Stable supply of starting intermediate of APIs