Drug Master File (DMF)
A DMF is a type of “API” or “Application Programming Interface”. An API is a collection of functions used to access functionality provided by another program. For example, an API might allow one application to call into another application to retrieve certain types of records within the database. In this case, the API would consist of the function calls that allowed the calling application to perform the desired task.
More information about Drug Master File (DMF)
Submissions,manufacturing,types,list,drugs,guidance,material,contents,review,party,drug product,drug substances,letter,format,Packaging materials.
Regulatory requirements,request,drug substance intermediate,Food and Drug Administration,drug master file,human drugs,letter of intent,form,complete list,requirements,company,sections,version,drug application.
Human drug products,acknowledgement letter,Cover letter,acknowledgment letter,manufacturing sites,manufacturing procedures,subsequent submissions,original submission,review process,raw materials,Technical contents,administrative content.
Pharmaceutical companies,address,activity status,public availability,abbreviated application,master files,analytical procedures,Center for Drug Evaluation,drug master file holder,drug product manufacturers,drug product intermediate,drug manufacturer,generic drugs,transmittal letter,letter of access,deficiency letters,electronic format,correct format,manufacturing process,contract manufacturing facilities,manufacturing processes,DMF-related submission questions,electronic submissions,Guidance for Industry,draft guidance,(5) FDA-accepted reference information,finished dosage form,electronic form,Health Canada,current list,list of persons authorized,starting materials,email address,authorized parties,equipment,equipment capabilities,Current version,inactive status,International Council for Harmonisation,International Organization for Standardization,Export Application,current thinking,floor plans,operational layout,5901-B Ammendale Rd.,biological products,complete reference,incorporation by reference,drug applicant,Agent Appointment Letter,process hold letter,Commitment letter,non-eCTD format,non-eCTD or eCTD format,eCTD format,proper non-eCTD or eCTD format,incorrect format,Manufacturing Site, Facilities,manufacturing flows,Identification of submission,Guidance Document on Post-Drug Identification Number,applicable guidance documents,Guidance Document – Quality,target review time,Administrative Review,ANDA review process,approval review,Administrative Information,non-confidential business information,Confidential Business Information,Manufacture Information,Manufacture Information S.2,Dosage forms,crystalline form,Type IV MF,Type V DMF,Type II,health,Health Canada’s,human health,Enhanced Content – Table,filing requirements,formatting requirements,Chinese companies,headquarters address,Authorized Third Party,responses to clarification requests,calendar day clarification request,Controls Section of an Application,declaration of access section,Facilities and Equipment,currents version,active status,International Council.