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  • 1.  API DMF stability question

    Posted 15-Jul-2017 08:54

    I know FDA requires a minimum of 6 months stability on 3 lots of finished product to be filed in the ANDA at filing time or the ANDA will no longer be accepted.  I have a client who wants to file a Type II DMF for an API, has at least 7 lots on stability (and it's stable as table salt) and want to file their DMF with 3 months data and at least get the number assigned and the DMF "accepted" and then update the DMF with additional stability at the same time their customer files their ANDA and references the DMF.  OK?

     

    Christopher Smith, CQE, RAC

    President, Coastal Pharmaceutical Consultants, Inc. ®

    7950 Old River Road, Burgaw, NC 28425 USA

    910-259-8877 (land)

    910-789-1232 (mobile)

    chrissmith@coastalpharmaconsultants.com

     



  • 2.  RE: API DMF stability question

    Posted 15-Jul-2017 09:09
    ​Yes, if you see the review process below of Type II DMF when the ANDA is submitted.
    When you submit ANDA, please advise the company to include LOA to Type II DMF. Since the 6-month data will be submitted at the same time as the ANDA, the FDA will only look at the DMF after receiving the LOA to DMF via the ANDA submission. So when they review the DMF not only for stability data but for all other critical information, the 6 months data will be there already for them to review. FYI-DMFs are not reviewed until the LOA to DMF is received by the FDA review division via ANDA, NDA or supplements/amendments etc.....

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    GRSAOnline
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    Original Message


  • 3.  RE: API DMF stability question

    Posted 15-Jul-2017 09:18
    ​​Sorry, after reviewing your question again, you said finished product stability data? I am not clear with your question. Are you referring to API stability data or finished product stability data? Finished product stability data will be submitted in the ANDA not via DMF so you may need 6 months finished product data for filing the ANDA if that's the Generic division requirement for ANDA submission.

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    GRSAOnline
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    Original Message


  • 4.  RE: API DMF stability question

    Posted 17-Jul-2017 08:22

    ​Yes it is acceptable to file the type II DMF with 3 month stability data. For the DMF to be considered complete (assuming it's for a generic application), the requirement is to submit the release data and one additional time point for at least one lot (refer to FDA's stability guidance). 
    I also noticed that you mentioned that your client wants to "at least get a DMF number assigned", please note that if they're filing an electronic DMF the DMF number is pre-assigned by the FDA i.e. your client would have to request the number from the FDA (instructions are on FDA's website).

    Hope this helps!

    Sabrina


    Original Message


  • 5.  RE: API DMF stability question

    Posted 17-Jul-2017 10:01
    Agree with Sabrina.

    Please find attached reference for more clarity.

    Reference # 1:          Page # 18

    Current Regulatory Practice
    in Type II API DMF Review


    Reference # 2:        Question # 30

    GPhA CMC 2014 Texting Questions.





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    Gaurang Bhavsar, MS, RAC
    Scientist-II, R&D and RA
    Sunrise Pharmaceutical, Inc.
    Rahway, NJ 07065
    USA
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    Attachment(s)

    pdf
    CMC_2014_QA (1).pdf   168 KB 1 version
    pdf
    D1S7_Zhang_SLIDES.pdf   1.91 MB 1 version
    Original Message


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