ANDA CHECKLIST FOR CTD FORMAT - MAX-Sourcing
3. Type II DMF number for API 4. CFN or FEI numbers 3.2.S.3 Characterization 3.2.S.4 Control of Drug Substance (Active Pharmaceutical Ingredient) 3.2.S.4.1 Specification Testing specifications and data from drug substance manufacturer(s) 3.2.S.4.2 Analytical Procedures
Download ANDA CHECKLIST FOR CTD FORMAT - MAX-Sourcing
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