Silica Gel Pharma Grade
Drug Master File approvals

 Approval, Technology, DMF, Consultants, Machinery, Market
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Information  at a Glance Contents on the CD ROM
  • 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
Basics DMF
  • What is DMF
  • Global Perspective
  • DMF Basics
  • DMF types
  • FDA
DMF Approval Information
  • DMF Procedures
  • Submission Guidelines
  • Providing Regulatory Submissions in Electronic Format
  • Electronic Format
  • Faq
  • Registration in Canada
  • Regulations - Japan

DMF Registration Consultancy

  • Complying with FDA Regulations
  • Contacts of Consultant
  • Consultant - India
  • FDA Agent Services
Companies with DMF  Certified Products
  • Chinese Company
  • Desiccant Sachet - China
  • Japanese Company
  • German Company
  • Company from Germany
  • German Company
  • Company - USA
  • Company - China
  • Company - Germany
  • Company - Japan
  • List of companies with FDA
  • Use of Type III Drug Master Files in Product Registrations

Plant & Equipment

  • Adsorption Technology from Design to Turnkey plant
  • Silica Based HPLC Coloumn
  • Hybrid Silica Based Columns

Technology Details

  • Desiccants for Pharmaceutical
  • Custom Purification and separation/purification Technologies
  • Packing Materials
  • C18 Columns
  • Container Closure Systems
Technology Offer
  • Japanese technology & equipment - Chromatographic Purification
  • Silica Adsorption Technology
Market Scenario
  • Silica Gel Industry
  • Consultant - Pharmaceutical Grade Silica Gel Market

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