Topscience Biotech has successfully completed an on-site cGMP inspection conducted by the U.S. Food and Drug Administration (FDA) and has officially received the Establishment Inspection Report (EIR) issued by the FDA. The inspection was successfully concluded with zero deficiencies.
From August 31 to September 4, 2026, Topscience Biotech underwent an FDA cGMP on-site inspection. The inspection covered six core systems: quality, facilities and equipment, materials, production, laboratory controls, and packaging and labeling. Particular attention was given to a comprehensive review of the production and quality systems for sodium hyaluronate active pharmaceutical ingredients (APIs).
Passing the inspection with zero deficiencies marks a major milestone in the development of Topscience Biotech’s quality management system. It demonstrates that the company’s manufacturing quality management practices are aligned with the highest international regulatory standards and reinforces its compliance foundation for the consistent supply of high-quality bioactive ingredients to customers worldwide.
This achievement is built on Topscience Biotech’s 21 years of dedicated experience in the bioactive ingredients industry:
1. Standardized GMP Manufacturing Platform: The company has eight compliant GMP production workshops and established an end-to-end quality management system in strict accordance with international guidelines and requirements, including ICH and cGMP. Closed-loop quality control is implemented throughout the entire process, from incoming raw material inspection and acceptance to in-process manufacturing controls, finished-product testing, and release. The company has successfully passed on-site inspections by domestic and international regulatory authorities as well as leading pharmaceutical companies on multiple occasions.
2. Global API Regulatory Compliance: Topscience Biotech continues to strengthen its global regulatory registration framework and has obtained a range of authoritative qualifications, including China GMP, the EU Certificate of Suitability (CEP), Korea Drug Master File (KDMF), and India Form41. These credentials continuously enhance the international market access capabilities of its products and provide a solid foundation for global market expansion.
3. Core Technologies That Strengthen Ingredient Competitiveness: Leveraging its proprietary microbial fermentation technology platform, the company has established an early industrialization advantage in Sterile Sodium Hyaluronate and Pharmaceutical Grade Sodium Hyaluronate. It is also strategically expanding into emerging bioactive ingredient fields, including PDRN & PN and Medical Device Grade Chondroitin Sulfate Sodium. Through sustained in-house R&D and the establishment of robust, stable processes, the company rigorously ensures batch-to-batch consistency. Its products can meet the demanding requirements of high-standard end applications, including injectable applications.
4. Internal Quality Standards Exceeding Pharmacopoeial Requirements: Supported by standardized laboratories, the company has established internal quality standards that are more stringent than those specified in pharmacopoeias worldwide. It maintains meticulous control over impurity-related parameters, such as endotoxins, nucleic acids, and residual proteins, as well as critical quality attributes, including assay and molecular weight. This rigorous and refined quality management system provides a strong foundation for product stability, consistency, and high-end applications.
5. Customer-Centric, End-to-End Services: Topscience Biotech provides supporting technical solutions, sample testing assistance, and regulatory documentation support. Guided by its commitment to reliable supply and quality first, the company works with partners worldwide to build long-term relationships based on mutual trust and collaborative growth.
Achieving zero deficiencies in the FDA cGMP inspection is not only an important milestone, but also a new starting point in Topscience Biotech’s journey toward greater international development.
Looking ahead, Topscience Biotech will remain committed to quality leadership and innovation-driven growth, continue to bring strong momentum to the global pharmaceutical, aesthetic medicine, and biomaterials industries.