Drug Master File
Mailing address for filing original DMFs and all subsequent DMF documents (Category 3): Food and Drug Administration Center for Drug Evaluation and Research Central Document Room 5901-B Amendale Road Beltsville MD 20705-1266 Companies send two paper copies of all submissions to an existing paper DMF to the address above.
Drug Registration in Malaysia, Thailand, other Asia markets
The Thai FDA (TFDA), one of several agencies under the Ministry of Public Health (MPH), is the regulatory body administering drugs in Thailand. The Drug Control Division of the TFDA is responsible for registration, licensing, surveillance, inspection and adverse event monitoring for all pharmaceuticals and pharmaceutical companies in Thailand.
Regulatory Guidelines for Pharmaceutical Excipients
The DMF typically includes specifications and test methods for raw materials, in-process testing, and the finished excipient product, a complete description of the manufacturing process, safety data, packaging details, and label content. Submission of an excipient Drug Master File (DMF) to the FDA is not required by law or FDA regulations.
List of Drug Master Files (DMFs) | FDA
The list of DMFs, which is updated quarterly, contains DMFs RECEIVED by December 31, 2025, for which acknowledgment letters were sent before January 9, 2025. The list is current through DMF 037919
Acyclovir - Uses, DMF, Dossier, Manufacturer, Supplier, Licensing
DRUG PRODUCT COMPOSITION. OINTMENT;TOPICAL - 5%, CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION;ORAL - 200MG/5ML, TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness
- How to register a pharmaceutical product in Vietnam?
- All pharmaceutical products must be permitted by Drug Administration of Vietnam before marketing them in Vietnam. For obtaining the permission of Drug Administration of Vietnam, the manufacturer (applicant) must file an application dossier comprising of full particulars and documents as required in the Regulation on Registration of Drugs. Part II.
- Who oversees the registration of pharmaceutical products in Vietnam?
- The Drug Administration of Vietnam (DAV) is one of the divisions under the Ministry of Health (MoH) and it handles the overall responsibility for the registration of pharmaceutical products to market in Vietnam.
- How to register generic drugs in Vietnam?
- To register generic drugs in Vietnam, follow these steps to obtain a marketing registration certificate: 1. Review your product details and understand the regulatory requirements. 2. Submit your application dossier. 3. Undergo evaluation of your application dossier.
- How do I get a drug license in Vietnam?
- For obtaining the permission of Drug Administration of Vietnam, the manufacturer (applicant) must file an application dossier comprising of full particulars and documents as required in the Regulation on Registration of Drugs. Part II. Quality dossier; Part III. Pre-clinical dossier; Part IV. Clinical dossier. Part II. Quality dossier. Part III.
- What are the marketing approval procedures in Vietnam?
- Marketing approval procedures: Any drug moving in the market should be registered. They shall meet all the registration requirements concerning quality, safety and they must be following the regulation on the registration of drugs in Vietnam.
- How much does marketing authorization cost in Vietnam?
- The government Filing fee for marketing Authorization applications in Vietnam is between $220-300 USD. The exact cost depends on the specific requirements of the medicinal product, such as data confidentiality, bioequivalent dossier, or clinical dossier requirements. Do you need support or have queries on drug registration requirements?
