API Department (Quality Assessment)
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Assessment policy CADIFA Guidance Impurities ANVISA Guidelines Other Guidelines Pharmacopoeias ANVISA links Other links FAQ History
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Certificates catalogue CEP - Suspensions, Withdrawals, Restorarions
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Prequalified APIs Prequalified FPPs WHOPIRs (GMP database) IARC Monographs
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EMA

Eudra GMDP Nitrosamines Nitrosamines (ARBs)
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DMFs Nitrosamines Nitrosamines (ARBs) Drug Establishments Current Registration Site
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Working groups Quality for generics ASMF/DMF Database Lexicon of quality terms Criteria for when a separate ASMF/DMF should be submitted Guidance for Quality Assessors – Drug Substance