Timeline between filing a DMF and filing an ANDA

[ArchanaS (Archana Shetty)]

Do you know what is a typical timeline between filing a DMF and filing and ANDA?
For. e.g. If a generic company files a DMF in Jan / Feb, what could be an expected timeline to file ANDA? Can that be 2H 2023? Is this correct thinking?

[sunilrbudhkar]

Please note that generally, DMFs are filed by the manufacturers of APIs, Intermediates, Excipients, Colouring / flavouring agents, and Packaging components. And ANDAs are filed by generic drug product manufacturers.

[ArchanaS (Archana Shetty)]

First of all,
Thanks much for your reply.
I completely agree that DMF mostly filed by manufacturers of API. Irrespective that, is there any specific timeline for the generic drug company to file the ANDA within stipulated timeline?. So my additional questions are:

1. In hypothetical question, if Sun Pharma has just filed the DMF for lanreotide (which I found from US FDA website) in Jan 2023. Does FDA has specifications that Sun Pharma needs to file the ANDA within the same year?
2. Or there is any validity for DMF approval by FDA and company to file ANDA?

Your guidance on this will be very helpful.

[sunilrbudhkar]

Thanks for your feedback about my initial response.
First of all, please note that DMF is never approved OR rejected. Please note the following,

As of October 1, 2012, under the Generic Drug User Fee Amendments of 2012, commonly referred to as GDUFA:2
 DMF holders are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application
 Type II API DMFs must undergo an FDA completeness Assessment (CA)
The guidance makes recommendations about the information that should be included in the DMF to facilitate a GDUFA CA.
The guidance does not apply to Type II API DMFs used to support new drug applications (NDAs), biologics license applications (BLAs), other submissions that are not generic drug submissions, or any other types of DMFs.

• Completeness Assessments (CA) for Type II API DMFs Under GDUFA
  FDA will perform a CA once a DMF holder files a Type II API DMF with the Form FDA 3794 and there is an initial verification of the fee payment.
  The CA does not replace the full scientific review, which determines whether the information contained in the DMF is adequate to support an ANDA regulatory action.
  In brief, FDA will undertake a CA to determine the following:
   Is the DMF active?
   Has the fee been paid?
   Has the DMF been previously reviewed?
   Does the DMF pertain to a single API?
   Does the DMF contain certain administrative information?
   Does the DMF contain all the information necessary to enable a scientific review?12
   Is the DMF written in English?

FDA will conduct the CA by determining the answers to a series of questions listed in the CA Checklist, which is included in Appendix 1. DMFs for which the fee has been paid and which have been found complete in accordance with the criteria for a CA set out in the CA Checklist will be identified on FDA’s public Web site as available for reference in support of a generic drug submission.
FDA will use the CA Checklist to perform the CA.
FDA will complete the administrative part of the CA Checklist (i.e., “General Information”) during the CA. If the DMF is incomplete, FDA will send the DMF holder a GDUFA DMF Incomplete Letter.
Following the CA, FDA will find the DMF either complete or incomplete.

If the DMF is found complete, FDA will post the DMF number on a publicly available list on FDA’s Web site to indicate the DMF is available for reference by generic drug submission applicants.
If the DMF is found incomplete, the CA findings and comments will be compiled in a GDUFA DMF Incomplete Letter to the DMF holder that explains why the DMF was deemed incomplete.
To remedy a GDUFA DMF Incomplete Letter and pass the CA, the DMF holder should submit an amendment to its DMF to correct the deficiencies identified in the Incomplete Letter, or, if FDA has determined that the DMF should undergo a complete update, the DMF holder should resubmit the DMF with that update. FDA will then assess the revised DMF’s completeness. If there are no deficiencies at this time, FDA will declare the DMF to be complete and to have passed the CA.
FDA will make the DMF number publicly available on its Web site.

Therefore, there is no direct implication on the submission of ANDA with respect to that of DMF.