- A Drug Master File (DMF) is a
submission to the Food and Drug Administration (FDA) that may be
used to provide confidential detailed information about facilities,
processes, or articles used in the manufacturing, processing,
packaging, and storing of one or more human drugs.
- Beginning on May 5, 2018, new
DMFs, as well as all documents submitted to existing DMFs, must be
submitted using the Electronic Common Technical Document (eCTD).
- Drug master files are a tool to
enable sharing of trade secrets with FDA without disclosing that
information with the pharmaceutical manufacturer
- Type III DMFs, which are used for
container closure system (packaging) and device and delivery system
component materials and proposes an approach for use of the DMF
system that encourages collaboration between the pharmaceutical
company and the packaging material supplier
- Materials or components described
in Type III DMFs are not typically manufactured by the
pharmaceutical company; instead, the company procures them from a
supplier
- The appointment of a US Agent is
a mandatory requirement for foreign companies who wish to sell drugs
or pharmaceuticals, medical devices, food and dietary supplements,
in United States
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Basics DMF
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What is DMF
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Global Perspective
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DMF Basics
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DMF types
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FDA
DMF Approval
Information
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DMF Procedures
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Submission Guidelines
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Providing Regulatory Submissions in
Electronic Format
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Electronic Format
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Faq
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Registration in Canada
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Regulations - Japan
DMF Registration Consultancy
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Complying with FDA Regulations
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Contacts of Consultant
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Consultant - India
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FDA Agent Services
Companies with DMF Certified Products
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Chinese Company
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Desiccant Sachet
- China
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Japanese Company
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German Company
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Company from
Germany
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German Company
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Company - USA
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Company - China
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Company -
Germany
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Company - Japan
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List of companies
with FDA
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Type III DMF
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Use of Type III Drug Master Files in Product
Registrations
Plant &
Equipment
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Adsorption Technology from Design to
Turnkey plant
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Silica Based HPLC Coloumn
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Hybrid Silica Based Columns
Technology
Details
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Desiccants for
Pharmaceutical
Applications
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Custom Purification
and separation/purification Technologies
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Packing Materials
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C18 Columns
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Container Closure
Systems
Technology
Offer
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Japanese
technology & equipment - Chromatographic Purification
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Silica
Adsorption Technology
Market
Scenario
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Silica Gel Industry
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Consultant - Pharmaceutical Grade
Silica Gel Market
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