Jiangsu Dongkekangde Pharmaceutical Co., Ltd. Successfully Obtains Drug Production License (Category B)

Through the unwavering efforts of the Dongkekangde team, Jiangsu Dongkekangde Pharmaceutical Co., Ltd. was officially granted the Drug Production License (Category B) by the Jiangsu Provincial Medical Products Administration in September 2022.

About the Drug Production License (Category B): The Drug Production License (Category B) is required when a Marketing Authorization Holder (MAH) delegates drug manufacturing to third-party producers. The MAH system, a regulatory mechanism implemented by China’s National Medical Products Administration (NMPA), separates drug marketing authorization from production authorization. Under this system, MAHs may obtain marketing authorization through contract manufacturing while assuming full legal responsibility for drug safety, efficacy, and quality control.

The approval of the Drug Production License (Category B) marks a critical milestone for Dongkekangde, signifying its enhanced capabilities in providing full-industry-chain pharmaceutical services under the MAH framework. This achievement accelerates the development of Dongkekangde’s MAH certification and conversion platform. As an MAH, Dongkekangde has established a regulatory-compliant, high-quality, and efficient management system covering the entire drug lifecycle, including:

· Research and Development (R&D)

· Technology Transfer

· Manufacturing

· Pharmacovigilance

· Risk Management

· Liability Compensation

This comprehensive system ensures robust post-market quality assurance.

· About Dongkekangde

Jiangsu Dongkekangde Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Nanjing Caremo Biomedical Co., Ltd., is a service-oriented platform company focused on drug R&D, MAH certification, and product conversion. The company boasts a highly skilled R&D team with extensive project development experience and has established a comprehensive drug R&D quality management system to ensure compliance across all research stages. As a pioneer in MAH certification and conversion, the company has implemented a rigorous MAH product certification quality management system and project operation management framework, including third-party audits, selection of contract manufacturers, and quality system guidance. Currently, the company maintains a robust portfolio of MAH-certified products, covering innovative drugs, improved new drugs, complex generic drugs, and products across multiple therapeutic areas and commercialization pipelines.