List Distributor or Manufacturer

GOOD MANUFACTURING PRACTICE (cGMP) US FOOD AND DRUG ADMINISTRATION (FDA)
1

Hi,

I’m writing a drug master file for submission to the US FDA. Some of our raw materials come from bulk commodity distributors. They are not the original manufacturers of the materials.

Should I list the distributor as the approved supplier or the original manufacturer?

Thanks,

2

I would think you would want to list the manufacturer as they would be the ones who would have the relative information on the materials.

Whereas the distributor would most likely only have information pertaining to the shipment.

Just my opinion.