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API DMF (Drug Master File)
Qvents
1 minute read
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Home
Guidelines
API DMF (Drug Master File)
Updated on October 11, 2023
Home
Guidelines
API DMF (Drug Master File)
Updated on October 11, 2023
USFDA
:
Drug Master Files: Guidelines
USFDA
:
Drug Master File (DMF) Templates
USFDA
:
Drug Master Files Guidance for Industry
:
DRAFT GUIDANCE
USFDA
:
M4: The CTD — Quality Guidance
EMA (Europe):
Active substance master file procedure
–
Scientific guideline
EDQM
:
Guidance for Electronic submissions for Certificates of Suitability (CEP) applications
ICH M4 :
The Common Technical Document Guidance
WHO
:
Guidelines on active pharmaceutical ingredient master file procedure (2008)
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