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Completion of PIC/S Participating Authorities' Audits of Kexing Biopharm's licensed Product Infliximab for Injection

Article source:Kexing BiopharmApr 08,2024View: 367

The product infliximab for injection, licensed by Kexing Biopharm, has recently experienced a wave of encouraging news regarding its international commercialization. After receiving the site GMP inspection by the Brazilian Health Regulatory Agency (ANVISA), a Participating Authority of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), in January 2024, the product is officially notified of the qualification for ANVISA's GMP certification. In addition, this month, the product has undergone a site GMP audit by another PIC/S Participating Authority, the Indonesian Food and Drug Authority (BPOM).


Kexing Biopharm


Since its accession to PIC/S on January 1, 2021, ANVISA has enjoyed a high reputation globally for its standard and stringent GMP audit regulations. In particular, the regulatory approval processes for biosimilar drugs are exceptionally stringent to uphold the high quality, efficacy, and safety standards similar to that of originator drugs. The successful GMP certification by ANVISA will expedite the product marketing process in Brazil and pave the way for its entry into countries of other PIC/S Participating Authorities and emerging markets in the future.


In addition, Kexing Biopharm has been exploring the Indonesian pharmaceutical market for nearly 20 years. The company's proprietary product, human erythropoietin (EPO), has been present in Indonesia since 2005, gaining popularity and increasing market share. The Indonesian pharmaceutical market has become a mature market for Kexing Biopharm collaborating with the top five pharmaceutical companies and the largest healthcare providers in Indonesia.


Kexing Biopharm


Over the past couple of years, Kexing has been dedicated to advancing the registration and accessibility of various imported products in the global cooperative region. In terms of infliximab, progress has been remarkable in the overseas factory inspection since the third quarter of 2023. As the international commercialization efforts of products introduced overseas progress, Kexing Biopharm has witnessed a rise in brand influence and further enhanced its development of a robust platform to promote Chinese high-quality drugs globally.

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