APIs CRDMO
We provide process route design, development and optimization for innovative and generic drugs, and provide professional services in quality research, process validation, product life cycle management and process safety assessment based on the QbD concept.
We provides customers with CMO and CRDMO services for APIs, empowering drug marketing authorization holders.
We use our professional chemical technology platform to provide services and solutions for preclinical drug candidate discovery for the global biopharmaceutical industry (academic and industrial).
20+
years of research experience
Development and production services
Provide core raw materials and solutions to the global biopharmaceutical industry (academic and industrial), covering the preclinical stage to the commercialization stage.
GMP industrial production experience
Flexible multifunctional production workshop
Production lines from kilograms to tons
Continuously optimize commercial production projects
We have a cGMP API production line that complies with IND reporting in both China and the United States. From preclinical trial synthesis and process development to commercial production, we deeply integrate with the entire supply chain system of the enterprise, including R&D, procurement, and production. From milligrams, grams to kilograms, our process production can be flexibly adjusted according to customer requirements and R&D stages, providing companies with innovative process R&D and large-scale production services.
From process design QBD, laboratory process development, commercial production to data registration and declaration. Our rigorous and experienced analysis and quality inspection team provides analytical services and quality control for the project throughout the entire process. And offer a full range of analytical research services, including analytical method development and validation, process validation, impurity identification and separation, quality studies for APIs and intermediates, and stability testing for APIs.
With years of experience and laboratory construction, our Pharmaceutical's process department can not only provide customers with R&D, analytical testing and stability research services for generic drugs, but also R&D, production, analytical testing and stability research services for innovative drugs in Phase I and Phase II clinical trials. We gradually develop from R&D processes to commercial production, providing customers with CMO and CDMO services for raw materials, and empowering drug marketing authorization holders.
Help customers choose and develop API process routes that are stable and reliable in quality, low in cost, safe in process, environmentally friendly and suitable for large-scale production.
Production process optimization
Applying the QBD concept to the R&D of API processes, we are committed to tailoring appropriate process routes for customers and optimizing API production processes to improve product quality and process efficiency.
Clinical sample production
We offer services for the confirmation of small-scale processes for active API production, safety evaluation batch production, pilot-scale production, and GMP-compliant API production. Our capabilities include the production of clinical Phase I and Phase II samples, as well as advanced intermediates.
We provide services such as impurity identification and separation, quality research, and stability testing of API to meet the requirements of regulations and ICH guidelines.
Generic Drug Process Research
We provide development, optimization, production and filing (DMF) services for generic drug API production processes.
