Pharmail

Updated Drug Master Files for filtration devices now available

We are pleased to announce that we have updated and revised the United States Drug Master Files (DMFs) for our Durapore®, Millipore Express®, Viresolve® and Viresolve® NFR Filters with Retropore® membrane filtration devices. In addition, we have transferred the DMFs to CTD format and submitted the DMFs for Millipore Express® and Viresolve® NFR Filters with Retropore® filters via the electronic gateway (eCTD submission) to the U.S. FDA. The electronic submission of the DMFs for Durapore® and Viresolve® filtration devices will soon follow. To ensure you remain informed on relevant product changes, please ask us for a Letter of Authorization (LoA). We will be happy to issue a LoA after having received the required information about your drug product.

The FDA can now easily evaluate these confidential documents that include descriptions of the manufacturing process and test procedures in connection with drug product applications, without further interaction with the applicant. At Merck, our goal is to help you facilitate your drug approval process, answering any questions you might have. You can rely on a hassle-free process when you use our products for your sterile filtration and retrovirus removal needs.

For more information, please contact us.

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