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Related News: Exceeding impurities in the drug substance may cause the product and its preparation to be recalled. The company receives an FDA warning letter or a CEP certificate suspension, which in turn will cause customer compensation, product recall costs, and asset impairment losses to affect the company’s performance.4-amino-N-Boc-L-fenilalanina CAS:55533-24-9 API (Active Pharmaceutical Ingredient) means the active ingredient which is contained in medicine.(3S)-6,7-dimethoxy-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid The clinical trial International Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency.147-94-4 The quality of the drug substance determines the quality of the preparation, so its quality standards are very strict. Countries around the world have formulated strict national pharmacopoeia standards and quality control methods for their widely used drug substances.At the same time, through years of imitation and advanced technology learning, more and more domestic companies have participated in the field of highly original and characteristic APIs.