In March 2026, MRKare Pharma (www.kemrocmed.com ) successfully passed the on-site inspection for new API product registration organized by the Center for Food and Drug Inspection of NMPA (www.cfdi.org.cn ). This marks another key milestone for the facility within one year, following the obtainment of its “Pharmaceutical Production License” in March 2025.
MRKare Pharma is a newly established HP-API GMP facility under the guidance of gempex China (www.gempexchina.com ), with its GMP system fully aligned with Chinese, European and US standards. Previously, the facility had passed on-site inspection by the Guangdong Provincial Medical Products Administration (mpa.gd.gov.cn) and obtained the "Pharmaceutical Production License" in March 2025. This latest successful inspection for MRKare Pharma not only proves the compliance of the entire production system's software and hardware systems, but also indicates that it can stably produce qualified products within this system, laying a foundation for the subsequent development of the enterprise to reach a higher level.
gempex China is a professional GMP consulting and implementation agency established in Mannheim, Germany in 2002, with branches in China, Switzerland. It is dedicated to providing compliant, efficient and executable GMP solutions for life science enterprises worldwide. After 24 years of development, gempex has grown to include over 60 experienced GMP experts. The company has executed more than 5,000 projects worldwide, served over 1,000 clients, covered over 20 countries, and established long-term cooperative relationships with numerous well-known pharmaceutical companies.
MRKare Pharma is a compliant HP-API GMP factory, focusing on the production of high-potency drugs and deuterated drugs. It is capable of conducting the production and supply of commercial batches of APIs, and can provide CDMO services for innovative drugs, covering compliant production requirements for chemical APIs from pre-clinical to Phase II clinical trials, with the driving force behind the R&D works in Guangzhou KemRocMed Co., Ltd. .
To learn more about GMP-related insights, visit www.gempexchina.com/gmp-knowledge for further information on GMP services offered by gempex Consulting.
For specific compliance inquiries, please contact us via:
Hotline: 400 166 2002
Email: info-cn@gempex.com
About gempex Consulting
For 24 years, gempex has been deeply committed to the field of GMP compliance, delivering compliant, efficient, and actionable GMP solutions to life science enterprises worldwide. We help pharmaceutical companies, biotech firms, API/excipient/packaging material manufacturers, and medical device developers meet GMP standards—including NMPA, EU, FDA, and PIC/S—while reducing compliance and drug safety risks.
Today, gempex boasts over 60 experienced GMP experts, has successfully completed more than 5,000 projects globally, and has provided professional services to over 1,000 clients. With operations in more than 20 countries, we have established long-term partnerships with numerous renowned pharmaceutical companies.
