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Setting and looking up to a higher quality standard as the company’s principle

Two decades of perseverance and the pursuit of excellence. Advanced production process, stringent quality control, and rigorous product testing are all aimed at ensuring that every batch of products meets the quality specifications of different countries.The quality of Ursodeoxycholic Acid (UDCA) complies with the current pharmacopoeia specifications of major countries and regions, including CP, EP, USP and JP. Bellingbio APIs have successfully obtained official registration approvals from China, the European Union, Japan, South Korea, Russia, India and Bangladesh, and have passed the on-site inspection by the US FDA. Belling Bio provides high purity, high stability, and high efficacy raw materials for the pharmaceutical industry.

        Perfect quality management system: The GMP management system has been established based on ICH Q7 and international GMP guidelines to guarantee the quality management of entire life cycle of drugs.

       Professional quality management team:A quality management team of over 100 members led by Qualified Person, to ensure quality control throughout the entire life cycle of drug production. The QC Laboratory, which includes physicochemical analysis, instrumental analysis, and microbiological analysis, ensures the use of well-controlled materials to obtain pharmaceutical products that meet the expected quality and patient requirements.

        Advanced testing equipment: The QC Laboratory is equipped with advanced equipment, such as Agilent HPLC and GC, Agilent TOF, Waters HPLC, Thermo Fisher HPLC and HPIC, GE TOC, Shimadzu HPLC and GC, Shimadzu AAS, Malvern Mastersizer,  FTIR Spectrometers and so on.

       Modern production system:Manufacturing process has undergone continuous optimization for more than ten years, with strong advantages in capacity, quality, and cost; workshops are equipped with DCS automated control system to achieve closed and automated production operations and to visualize the progress of the production process.