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DMF (Drug Master File) Submission for API - Do I need a US agent?

S

silab1001

#1
#1
Hi all,

I'm an API (active pharmaceutical ingredients) producer outside the US seeking to submit DMF's
Do I need an US agent to do the filing or annual reporting or can it be done by ourselves?
Is there a requirement of an US agent at any part of the DMF filing?

Thanks in advance and have great day~!
 
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Marc

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#2
#2
Re: DMF Submission - Do I need a US agent?

DMF = Device Master File or Drug Master File?
 
S

silab1001

#3
#3
Re: DMF Submission - Do I need a US agent?

Drug Master File for Active Pharmaceutical Ingredients
 
R

raghu_1968

Involved In Discussions
#4
#4
silab1001 said:
Hi all,

I'm an API (active pharmaceutical ingredients) producer outside the US seeking to submit DMF's
Do I need an US agent to do the filing or annual reporting or can it be done by ourselves?
Is there a requirement of an US agent at any part of the DMF filing?

Thanks in advance and have great day~!
Click to expand...
Filing or annual reporting shall be done directly with FDA. Agents are not required to deal this.

US agents are mandatory for : Getting the Facility registration (number) and the product “NDC” (National Drug Code) number. Because of this most of the companies outside US fix the agent for both the purpose ie for facility registration, NDC number and also for DMF filing or annual reporting.
 
M

Manojzacharias

#5
#5
hi silab1001,
for DMF US Agent is not a regulatory requirement,
but an experianced US Agent can help you in proper submission.
 
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