Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product

The Generic Drug User Fee Amendments (GDUFA) include provisions for DMF fees, a completeness assessment, and communications with DMF holders for Type II DMFs for drug substances (active pharmaceutical ingredients (APIs)) used to support ANDAs. These provisions do not apply to other types of DMFs or to Type II DMFs used to exclusively support NDAs or INDs. For more information about GDUFA as it relates to Type II DMFs, see:

DMF enhancements under GDUFA II

Completeness Assessments for Type II API DMFs Under GDUFA (guidance for industry)

A completeness assessment is a series of questions that must be satisfied for a DMF to be made publicly available on FDA's website. It does not replace the full scientific review to determine the adequacy of a DMF to support an ANDA regulatory action. Send inquiries concerning the status of a DMF that is being reviewed for a completeness assessment to [email protected].

List of Type II DMFs Available for Reference

A list of DMFs that have passed the completeness assessment and are available for reference by ANDAs under GDUFA.

List of Drug Master Files (DMFs)

For submissions of sterility assurance information, see:

MAPP 5040.1 Product Quality Microbiology Information in the Common Technical Document—Quality (CTD-Q)

Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (guidance for industry)

Additional Resources

Q1A(R2) Stability Testing of New Drug Substances and Products (ICH guidance for industry)

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (ICH guidance for industry; see also Q7 Questions and Answers)

Q11 Development and Manufacture of Drug Substances  (ICH guidance for industry; see also Q11 Questions and Answers)

HDPE BOTTLES FOR ORAL SOLID PREPARATION

PASTIC BOTTLES AND CAPS WITH DRYING AGENT

EYE DROPPER BOTTLE

CYCLIC OLEFIN POLYMERS MEDICINAL PLASTIC BOTTLES

Source form FDA