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  • 1.  Multiple API suppliers

    Posted 06-Aug-2014 09:27
    Hello All,

    Can we submit an ANDA submission with two API suppliers?. If yes, do we need to make 3 batches of each (API supplier) for stability data? Once the ANDA is approved, how can we switch between the suppliers. What kind of studies would be needed to show equivalency.

    Appreciate your input on this.


    Thanks,
    Mehul

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    Mehul Govani
    Regulatory Specialist
    United States
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  • 2.  RE:Multiple API suppliers

    Posted 07-Aug-2014 04:10

    Hi Mehul;
    If you propose to add additional source of api for the same drug substance then you should provide the following cmc information.
    - comparision n justification of comparibility of physiochemical properties n impurities of the drug substance from each source.
    - stability from 3 batches of drug product from first api source used in BE studies
    - A single pilot scale batch of Drug product bio strength manf by using second api source.
    - stab data on the strength manf from each api source.

    Details on the requirements can be referred from the usfda guidance doc ANDAs: stability testing of drug substance and products question n. Answers. Section c: drug product manufacturing n packing Q.12

    Regards.
    -------------------------------------------
    Sandesh Shetty
    Apotex
    Bangalore
    India
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    Original Message


  • 3.  RE: Multiple API suppliers

    Posted 07-Aug-2014 09:00
    FDA issued an ANDA guidance on June 2013 and as a result, industry made lots of comments.  In response to those comments, FDA provides answers.  The answers of which are shown in the FDA's ANDA guidance issued dated May 2014.  

    To answer your question, please refer to question 12.  

    OR

    Please refer to http://www.fdaguidance.net/2014/07/andas-stability-testing-of-drug-substances-and-products/

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    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 4.  RE: Multiple API suppliers

    Posted 07-Aug-2014 10:33
    Thank you Sandesh and David. This was very helpful and informative.

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    Mehul Govani
    United States
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    Original Message