Hi-tech spring Company successfully obtained the "I" status registration number for 1,3-butanediol as a pharmaceutical excipient, opening a new chapter of compliant application

Recently, in accordance with the requirements of the "Announcement of the National Medical Products Administration on Further Improving the Work Related to the Associated Review, Approval, and Supervision of Drugs (No. 56, 2019)", the 1,3-butanediol independently developed by Hi-tech spring has officially passed the review and approval of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, obtaining a "I" status registration number. The acquisition of this qualification marks that Hi-tech spring's 1,3-butanediol has been recognized by the national drug regulatory authority in terms of quality, safety, and production process. It also lays the foundation for the compliant application in the global market and provides downstream customers with compliant and stable raw material supply. As an important high-end organic fine chemical, 1,3-butanediol can be applied in industries such as cosmetics, new energy, resin, chemical, food essence, and medicine. By obtaining the qualification for pharmaceutical excipients, not only does it expand the application boundaries of 1,3-butanediol, but it also promotes its value upgrade in the high-end market. Pharmaceutical excipients must strictly comply with national drug regulatory requirements, and passing the CDE filing is a "passport" to enter the high-end market. This rigorous application process not only reflects Hi-tech spring's high emphasis on compliance but also demonstrates its strong capabilities in quality management systems and technological research and development.

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