MRKare Pharma is an HP-API GMP-compliant manufacturing facility specializing in the production of highly potent pharmaceuticals and deuterated active ingredients (APIs). The company produces commercial batches of active ingredients and offers CDMO services for innovative pharmaceuticals. It complies with production requirements for chemical APIs from the preclinical phase through phase II clinical trials. Research and development efforts are led by Guangzhou KemRocMed Co., Ltd.
MRKare has now achieved a milestone in China’s HP-API landscape.
MRKare Pharma has successfully passed the NMPA’s on-site inspection for the licensing of a new active pharmaceutical ingredient - another important step forward, just one year after receiving its pharmaceutical manufacturing license.
The NMPA (National Medical Products Administration, formerly CFDA - China Food and Drug Administration) is the Chinese authority responsible for the registration and oversight of pharmaceuticals, medical devices, and cosmetics for the Chinese market.
gempex China, the Chinese subsidiary of gempex GmbH, was commissioned to provide design input and review, among other tasks, during the construction of the new production facility. The plant for highly potent active pharmaceutical ingredients (HP-API), built with the support of gempex China, meets GMP requirements in accordance with Chinese, European, and U.S. American standards. This achievement not only confirms the GMP compliance of the existing systems but also the plant’s ability to reliably manufacture high-quality, modern active ingredients.
For MRKare Pharma, this milestone provides a solid foundation for future growth and further development in the field of highly potent and innovative pharmaceuticals.
For questions regarding “Regulatory Affairs in China” or “GMP Consulting in China,” please contact Ralf Gengenbach, Managing Director of gempex GmbH, via contact@gempex.com.
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