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HomeDrugsDrug Master Files (DMF)DMF Examples › DMF Type V Examples

DMF Type V Examples

The following are examples of DMFs filed with the U.S. Food and drug Administration (U.S. FDA).

NOTE: The following is for informational purposes only. This is not a complete or comprehensive list. If you have questions about specific Type V DMFs, please   contact us.

Acceptance Testing Bioequivalance Study Biotech Production Building
CGMP Manufacturing Facility Clinical and Non-Clinical Studies Clinical Investigation Methods
Clinical Studies Contract Manufacturing Facilities Contract Sterilization Facilities
Curriculum Vitaes (CV) Drug Substance Manufacturing Explotab Feeding Study
Fastlab Pet Synthesizer Filling & Freeze Drying Methods Gamma Irradiation Facility
Mammalian Manufacturing Areas Manufacturing Facilities Non-Clinical Data
Preclinical Evaluations Preclinical Studies Procedures for Sterile Operations
Production Facilities Provisional Data Reports Reference Information
RSV Component Washing Process Safety Data Sterile and Non-Sterile Facilities
Sterile Manufacturing Facilities Sterile Processing Facilities Sterile Processing Procedures
Sterile Product Operations Sterilization Facility Sterilization Process
Sterilization Validation Package Supplementary Information SVP Facilities
Terminal Sterilization Program Toxicological Studies Toxicology Information
Toxicology Studies

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U.S. FDA Regulations:

U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420

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