Multiple API Manufacturers Obtain EU GMP and CEP Certifications, Accelerating Overseas Market Expansion

In terms of global API expansion, several companies have recently made significant progress.

EU GMP Certification: On July 31, a domestic API manufacturer announced that it had received GMP certificates from the Hamburg Health Authority in Germany for its heparin sodium API, enoxaparin sodium API, nadroparin calcium API, and chondroitin sulphate sodium API. Obtaining these GMP certificates from the Hamburg Health Authority confirms that the company can continue to market these four APIs in the European Union, providing a solid foundation for further expanding overseas sales.

CEP Certificate: On August 6, another API manufacturer announced that its wholly‑owned subsidiary had received a Certificate of Suitability to the European Pharmacopoeia (CEP) from the European Directorate for the Quality of Medicines & HealthCare for its iodixanol API. Obtaining the CEP certificate allows the API to be sold in international markets that recognise the CEP, positively impacting the company's further international expansion.

New API Approval: On July 29, a domestic bio‑engineering company announced that its wholly‑owned subsidiary (second‑level) had received a "Chemical API Marketing Authorisation Approval Notice" from the National Medical Products Administration for terlipressin acetate API. This approval marks that the product is now qualified for domestic market access, enriching the company's peptide API product pipeline and supporting sales growth in the API business.

Industry insiders note that in recent years, domestic API manufacturers have continued to intensify their global footprint, obtaining international certifications such as EU GMP and CEP to expand overseas markets. At the same time, newly approved high‑end API varieties in China are continually enriching the domestic API supply system, providing more stable and reliable raw material support for formulation production.