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ABOUT USHebei Guangxiang Pharmaceutical Co., Ltd. is specializing in the production of bulk pharmaceuticals, fine pharmaceuticals, intermediate compounds and biopharmaceutical preparations.
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INNOVATIONDevelops fine, series, high-end bulk pharmaceutical intermediates and innovative bulk pharmaceutical intermediates with high added value to build variety competition advantages.
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RECRUITGuangxiang has jointly established engineering laboratories, technology research centers and other high-level innovation platforms with CAS, Zhejiang University, Tianjin University and other universities.
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CONTACTWith stable production, high-quality and reliable service, the company's products have been sold to more than 80 countries such as the United States, the United Kingdom, Germany and the Netherlands
Guangxiang Pharmaceutical of Shijiazhuang Sihua Pharmaceutical Group Obtains EU CEP Certification for Caffeine
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TIME：2025-06-18
On June 17, caffeine, the core active pharmaceutical ingredient produced by Hebei Guangxiang Pharmaceutical Co., Ltd., a subsidiary of Shijiazhuang Sihua Pharmaceutical Group, officially obtained registration from the European Directorate for the Quality of Medicines & HealthCare (EDQM) and was awarded the European Pharmacopoeia Certificate of Suitability (CEP) for use in the EU. This milestone achievement marks a significant enhancement of Guangxiang Pharmaceutical’s position within the global high-end supply chain for caffeine.
According to reports, the CEP certificate issued by the EU’s EDQM—one of the world’s most stringent and influential pharmaceutical regulatory authorities—is widely regarded as the “golden key” for accessing the European and American markets. This registration entails rigorous review across the entire product lifecycle, including manufacturing processes, quality control, impurity profiling, and other critical aspects, with standards that far exceed those of typical international registrations.
“The successful attainment of the EU CEP authoritative certification for our caffeine products demonstrates that our quality control system fully complies with the European Pharmacopoeia standards and has reached world-class levels,” said Cui Jincheng, Manager of the Group’s International Certification Department.
Caffeine, as a critical active pharmaceutical ingredient and food and beverage additive widely used in the pharmaceutical, food, and beverage industries, has quality and purity that directly impact the efficacy and safety of the final product. Obtaining EU CEP certification this time not only signifies that Guangxiang Pharmaceutical’s caffeine products have been recognized by EU member states but also by other countries that have entered into mutual recognition agreements with the EU, thereby demonstrating exceptionally high industry recognition and market credibility.
Guangxiang Pharmaceutical is a large-scale pharmaceutical enterprise invested and constructed by Shijiazhuang Sihua Pharmaceutical Group in the Cangzhou Lingang Economic and Technological Development Zone. Capitalizing on the major strategic opportunities presented by the coordinated development of the Beijing–Tianjin–Hebei region, the Group has vigorously implemented a “API-plus-formulation” development strategy. Since commencing operations in 2019, Guangxiang Pharmaceutical has leveraged its innovation chain to enhance its value chain, fully tapping the research capabilities of leading universities and research institutes such as Tsinghua University, Tianjin University, and Nankai University. By employing advanced technologies—including continuous-flow microreactors and continuous crystallization—the company has continuously tackled challenges in optimizing API manufacturing processes, successfully resolving numerous common and critical technical bottlenecks in the production of products such as caffeine and metronidazole. As a result, both product yield and quality metrics have been significantly improved.
“We employ domestically leading crystal-form control technology, which enables precise regulation of particle size and bulk density to meet the diverse requirements of high-end customers in Europe and North America. This technology has significantly enhanced key quality attributes such as flowability for products like caffeine and metronidazole. In addition, our caffeine products have obtained carbon-footprint management certification, further bolstering customer trust in our offerings.” According to Cui Yongbin, Chairman of Guangxiang Pharmaceutical, the company has also successively achieved national GMP certification as well as international certifications including PMDA, BRC, FSSC 22000, KOSHER, and HALAL. Its caffeine products are now exported to more than 60 countries and regions worldwide, with both annual production and export volumes ranking among the highest in the country.
“The attainment of this certification has laid a solid foundation for Guangxiang Pharmaceutical’s future expansion into international markets,” said Cui Yongbin. He added that, as the global pharmaceutical industry chain continues to consolidate and upgrade, companies with international certification credentials will enjoy a distinct competitive edge. Leveraging its strengths in CEP registration and certification, Guangxiang Pharmaceutical will fully capitalize on its advantages in quality, brand reputation, and customer service to intensify its efforts in the internationalization of its active pharmaceutical ingredients, continuously enhance the global brand image and market share of its products, and accelerate the transition from “exporting products” to “exporting brands.” The company is committed to contributing greater Chinese expertise and innovation to the development of the global pharmaceutical industry.
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