Are individual DMF numbers required for the same product when it's supplied by plants in two different countries?
Are individual DMF numbers required for the same product when it's supplied by plants in two different countries?
Question
We make closures for the tooth paste industry. We have a DMF number in our USA plant but we want to supply the same product from our Mexican Plant. Do I need to register another DMF number?
Answer
If the products are substantially identical, you should be able to amend the DMF to identify the new facility in the Administrative Information section of the DMF. However, FDA has not been fully consistent on this question over the years as it is possible that the Agency may require a new DMF.
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