Drug Master File (FDA DMF)
Drug Master File (FDA DMF) is a confidential document submitted voluntarily to the FDA by human drug manufacturers, processors, packagers, and stores. DMF contains information about production facilities, processes, packaging, quality control, and storage products. FDA DMF is generally submitted by manufacturers of Active Pharmaceutical Ingredient (API), Drug Substance, Drug Intermediate Substance, and Drug Packaging Material.
Drug master file usually contains the components/ingredients, chemistry, process technology, quality controls either of drug substance, excipient, or packaging material. Drug Master File has a significant role in finished product drug applicants’ NDAs, ANDAs, and INDs. So, careful preparation of files by an expert is highly essential for successful submission.
Drug Master File Types
Drug Master File TYPE I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable).
Drug Master File TYPE II: Drug products or substances or intermediate and or materials used for drug preparation.
Drug Master File TYPE III: Packaging Material.
Drug Master File TYPE IV: Excipient or Colorant or Flavour/Essence or material used in the Preparation.
Drug Master File TYPE V: FDA Accepted Reference Information.
Regional DMFs:
The DMFs generated for regions (excluding USA and Europe) are covered under Regional DMFs for the following countries: Canada, China, Turkey, Brazil, Korea, South Africa, Australia, Syria, and Saudi Arabia. Regional guidelines of the respective countries must be followed for generation and submission of the Regional Drug Master Files.
FDA Registration
FDA registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, API, medical devices, or cosmetic products in the USA. Companies that manufacture, process, pack, or store these products in the United States may be required to register with the FDA. Here are some examples of the types of companies that require FDA registration:
It’s important to note that the FDA has specific registration requirements for each type of product, and the registration requirements for all kinds of companies are not the same.
US FDA Agent
All foreign Establishments must identify a US FDA Agent while in the registration process. This is a mandatory requirement, and without US FDA Agent, the registration cannot be completed. Neozenith Consulting Services provides US FDA Agent service to foreign food, drug, API, and medical device establishments.
FDA Registration Renewal
All Drug, API, and Medical Device establishments registered with FDA must renew their registration annually between October 1st and December 31st. Food facilities must renew their FDA registration between October 1st and December 31st of every even-numbered year (once every 2 years). The FDA may consider the products of companies that do not comply with FDA renewal requirements as misbranded and may lead to FDA detention of your products.
FDA Certification
FDA Registration or FDA registration number does not denote FDA certification or FDA approval of your facility or products. Any representation of the FDA registration number on the product label or labeling which implies FDA certification or FDA approval of a facility or product is misleading and may cause misbranding of the product.
FDA Certificate
FDA will not issue a registration certificate after completing the registration; also, FDA will not recognize a third-party registration certificate. Most Importers and Shipping companies always ask for an FDA registration certificate or proof of FDA registration from the manufacturer.
FDA Registration Fees
Neozenith Consulting Services offers the most competitive fees for FDA registration, US FDA agent service, NDC number request, Drug listing, Label review, and other services.
About Us
Neozenith Consulting Services is a globally recognized FDA, CE Marking, and ISO consulting firm headquartered in Madhya Pradesh, India with Associates and offices around the globe. At NCS, we provide a full range of consulting services to domestic establishments in FDA regulations.
If you are looking for assistance in FDA regulations, FDA registration, or US FDA Agent requirements, NCS will be the best choice. Our dedicated and experienced consultants can provide exceptional guidance on US FDA regulations. We always give you an accurate estimate of the total cost involved in each project; we will never put you in uncertainty with hourly consulting fees. NCS provides quality service at a reasonable price within a minimum time frame.
Our mission is to provide maximum benefits to our clients through the proper guidance in FDA regulations and provide the latest information about the changes in FDA regulations
