![]() This means that the APIs, excipients or packaging materials are registered and reviewed solely, but the technical linked review with finished drugs is not completed yet. This means that the APIs, excipients or packaging materials were approved to be used in finished drugs, but there are technical amendments that may significantly affect the quality, and the amendments are not reviewed yet. Dndc Pmma In Thf A Drug Master File (DMF) is a submission to the U.S. This means the MDF was found acceptable for filing after complete assessment, but the technical linked review with finished drugs is not completed yet. This means that the APIs, excipients or packaging materials are approved to be used in finished drugs. This means a DMF that has been closed either by the holder or by the FDA. I found this Polymer Handbook by Brandrup/Immergut, and found the dn/dc value as 0. This means that the DMF was found acceptable for filing, administratively, and has not been closed. Can anybody help me in finding the dn/dc value of PMMA standard in DMF. In China, all the DMF published with a DMF number indicates the Completeness Assessment is done, and the status shows the technical review progress.
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