I support a site that manufactures some commodity API. We have a customer of a distributor that is claiming the FDA requires them to have a quality agreement (QA) with the manufacturer of their API. They cited the FDA guidance "Contract Manufacturing Arrangements for Drugs". We responded that we were not a contract manufacturer for them (this is truly a commodity, we sell this API to dozens of manufacturers). I wondered if other manufacturers were being pushed by FDA under this guidance to require QA with commodity API manufacturers? For info, API manufacturer is in US, drug product manufacturer is in Greece. We would routinely agree if this was a direct customer, but this manufacturer purchased through a distributor and we have no direct relationship with them.
Thanks for any info
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Mary Todas RAC
Senior Manager Regulatory Affairs
Kalamazoo MI
United States
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