GuilinHwasun Fosfomycin Trometamol API Secures Dual Brazilian and EU Certifications, Accelerating Global Market Access

February 2026 — Guilin Hwasun Pharmaceutical Co., Ltd. has successfully secured consecutive certifications for its Fosfomycin Trometamol API: CEP (Certificate No.: CEP 2025-152-Rev 00) and the Brazilian GMP CBPF under PIC/s GMP standards. Combined with the Brazilian CADIFA certificate obtained in December 2025 (Certificate No.: CADIFA No.25351.373156/2024-33 Rev.001), we has achieved a "Triple Certification Breakthrough" for regulatory market access in Europe and Brazil within a short timeframe — marking a pivotal milestone in its global market expansion.

Previously, Lansoprazole API received CEP in 2014 (Certificate No.: R1-CEP 2012-198-Rev 00), and Omeprazole API successfully passed the on-site inspection by Japan's MAH (PMDA) in 2025. These latest EU and Brazilian certifications represent a concentrated demonstration of our technical manufacturing capabilities and quality management excellence, while further validating the global adaptability of its quality management system.

This breakthrough marks a significant elevation of our competitiveness in the international high-end pharmaceutical market. It not only opens critical pathways for products to enter core regulated markets worldwide but also establishes a solid foundation for the deepening of our global strategic layout.

Going forward, Guilin Hwasun Pharmaceutical will continue to center its operations on high-standard quality management systems, empowering domestic and international partners with superior products and services to advance the global pharmaceutical industry and propel the next phase of its global growth.