FDA ANDA Checklist

這是學名藥客戶在美要file 的ANDA檢核表
FDA ANDA Checklist <-可下載word檔

和API supplier比較有關的如下:

Module 1 Administrative
1.3.5.2 patent certification
Paragraph IV is listed here

1.4.1 LOA
TYPE II DMF authorization

1.12.12 Comparison with RLD
2. active ingredients

Module 2 Summary
2.3.S
Drug Substance (Active Pharmaceutical Ingredient)
2.3.S.1
General Information
2.3.S.2
Manufacture
2.3.S.3
Characterization
2.3.S.4
Control of Drug Substance
2.3.S.5
Reference Standards or Materials
2.3.S.6
Container Closure System
2.3.S.7 Stability

Module 3 (其中3.2.s 全部都重要)
Manufacturer
3.2.S.2.1
Manufacturer(s) (This section includes contract manufacturers and testing labs)
Drug Substance (Active Pharmaceutical Ingredient)
1. Name and Full Address(es)of the Facility(ies)
2. Function or Responsibility
3. Type II DMF number for API
4. CFN or FEI numbers