Raw Drug Materials and APIs
  • Raw Drug Material and Active Pharmaceutical Ingredients (APIs)
  • Packaging Material
  • Excipient, colorant, flavor, essence, or material used in their preparation
WHAT IS DRUG MASTER FILES (DMF)?
A submission to the US FDA that provides confidential detailed information about facilities, processes, packaging, and storage of a raw drug material or API for one or more human drugs.
MAJOR TYPES OF DMF
   Type II:Drug substance, drug substance intermediate, material used in their preparation, or drug product
   Type III:Packaging material
   Type IV:Excipient, colorant, flavor, essence, or material used in their preparation
PURPOSES OF A DMF
  • To be referenced by a party other than the DMF holder without disclosing the content of the DMF
  • To support an IND, an NDA, and ANDA, another DMF, an export application
  • To support amendments and supplements to any of the above
RBP OFFERS FOLLOWING PRODUCTS AND SERVICES
  • Auditing GMP facilities prior to U.S. FDA inspection
  • Preparing DMFs for raw drug materials and APIs
  • Submitting DMF to U.S. FDA until DMF number is obtained
  • Annual maintenance of registered DMFs
  • Writing response letters to the U.S. FDA and transmittal letters to affected parties
  • Transferring DMF ownership
  • Handling major reorganizations of a DMF
  • Notifying U.S. FDA to close a DMF
  • Identifying clients in need of raw drug materials and APIs