The Application for Clinical Trial of a Class 1 New Drug Developed by Nanjing Vcare to Assist its CDMO Partners has been Officially Accepted

2024-05-30

Recently, the application for clinical trial of a Class 1 new drug (capsule) developed by Nanjing Vcare to assist its CDMO partners has been officially accepted by the Center for Drug Evaluation (CDE).

This project was undertaken by Nanjing Vcare in conjunction with its affiliated production base, Hubei Tianshu Pharmaceutical Co., Ltd. ( "Tianshu Pharmaceutical"), which provided integrated CDMO services. It only took 9 months from the signing of the contract to the completion of the acceptance of the Investigational New Drug (IND) application. Nanjing Vcare has been deeply focused on the R&D and production services covering the whole industrial chain and the whole life cycle of chemical drugs. It has given full play to the industrialization advantages of Tianshu Pharmaceutical and provided services such as process development, toxicological sample supply, 30kg-level GMP production and release for this project, thus helping its clients' application for clinical trial of the Class 1 new drug to be officially accepted.

Nanjing Vcare has always been committed to building a one-stop CRO/CDMO service platform integrating "chemistry + pharmacy + medicine", continuously providing customers with efficient, convenient and high-quality CDMO services, constantly lowering the threshold for the production and R&D of new drugs, and helping more innovative drugs to enter the market successfully and benefit patients.

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PhaseⅠ Project of Tianshu Pharmaceutical, the Production Base of Nanjing Vcare, Successfully Passed the Completion Acceptance