Relying on our international standard quality system, we are a reliable and cost-effective production partner of our customers, providing long-term supply of intermediates and APIs from grams to tons. We have a production base of APIs in line with cGMP standards, committed to providing production and manufacturing services for small molecule drug research and development for customers at home and abroad.
Our production facilities include kilogram level laboratory, multi-functional production workshop and commercial production workshop. The specification of the reactor ranges from 2 to 5000 liters, and the equipment materials include glass lining and stainless steel, etc., which can complete the production of various complex intermediates and APIs.
We successfully provide all kinds of intermediates and APIs for our customers. The types of reactions that can be realized include hydrogenation (9 MPa), high temperature reaction (150°C), low temperature reaction (-80°C), etc. it has the ability to complete the API used for clinical phase I to phase III in line with cGMP standards for domestic and foreign customers.
We have the ability to：
— Carry out rapid and targeted process optimization and scale-up production for APIs needed in early clinical trials, including design / development of new synthesis routes or further optimization and improvement on existing synthesis routes.
— Choose the right crystal form for API.– Research and development of crystallization process for APIs and intermediates.
— Interpret and study the key process parameters to verify the production process of GMP or non GMP APIs.
— Design and develop a low-cost and safe synthetic route from kilogram scale-up to tonnage scale-up for the commercial production of APIs and intermediates.