Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi Everyone,

looking to shed some light...

I have company A (located in Europe) who manufactures API and ships the API to company B (also located in Europe) who is the holder and owner of the DMF. Company B ships the API to company C (located in Europe), who uses the API for further processing, and ships X amount to Company D (located in US).

Company A is the manufacturer
Company B is the supplier and owner of the DMF. The Certificate of Analysis is provided by company B.
Company C supplies x amount to company D

Who should drug list the API? Company A (manufacturer) or Company B (holder/owner of the DMF)?  Company B think they don't have to register because they are not the manufacturer even though they are the holder/owner of the DMF.  

Per the FD&C Act, looks like company A should list it...
"Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S."

Any thoughts? Comments?

Thank you for you help!

Company B is issuing the Certificate of Analysis which suggests to me that the QP responsible for issuing the Certificate is located at Company B, based on analytical data provided by Company A? If that is the case, then I might agree that they don't have to register since they are not manufacturing, preparing, propagating, compounding or processing the API. A Certificate of Analysis is expected of any supplier.  Ownership of the DMF I think is not relevant. However, if they are doing any analytical work on the API, they may need to register.

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 05-Feb-2019 10:49
From: Anonymous Member
Subject: drug listing requirement for foreign manufacturer

This message was posted by a user wishing to remain anonymous

Hi Everyone,

looking to shed some light...

I have company A (located in Europe) who manufactures API and ships the API to company B (also located in Europe) who is the holder and owner of the DMF. Company B ships the API to company C (located in Europe), who uses the API for further processing, and ships X amount to Company D (located in US).

Company A is the manufacturer
Company B is the supplier and owner of the DMF. The Certificate of Analysis is provided by company B.
Company C supplies x amount to company D

Who should drug list the API? Company A (manufacturer) or Company B (holder/owner of the DMF)?  Company B think they don't have to register because they are not the manufacturer even though they are the holder/owner of the DMF.

Per the FD&C Act, looks like company A should list it...
"Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S."

Any thoughts? Comments?

Thank you for you help!

Well let me start with this: both "To Register and Listing" are different and need to be submitted separately.

Company A and C: both are considered as manufacturer and need to register their site with FDA.
While Company B: is just a sponsor: A firm that does not participate in the manufacture or processing of a drug but instead markets and distributes under its own trade name, and labels a drug product/substance made by someone else, is referred to as "PLD". There are 2 scenarios in general with PLD's:

• PLDs do not have a registration or listing obligation for drugs they do not manufacture or process.
• PLDs may elect to submit listing information for a drug they do not manufacture or process directly to the FDA (mark my word here "Listing" not Registration)

If they list, they assume full responsibility for compliance with all listing requirements
If they do not list, the registered establishment producing the drug(s) must submit the drug listing information ( which I believe Company A needs to list as they are the actual manufacturer of API)

------------------------------
Amit Jain
United States
------------------------------

Original Message:
Sent: 05-Feb-2019 10:49
From: Anonymous Member
Subject: drug listing requirement for foreign manufacturer

This message was posted by a user wishing to remain anonymous

Hi Everyone,

looking to shed some light...

I have company A (located in Europe) who manufactures API and ships the API to company B (also located in Europe) who is the holder and owner of the DMF. Company B ships the API to company C (located in Europe), who uses the API for further processing, and ships X amount to Company D (located in US).

Company A is the manufacturer
Company B is the supplier and owner of the DMF. The Certificate of Analysis is provided by company B.
Company C supplies x amount to company D

Who should drug list the API? Company A (manufacturer) or Company B (holder/owner of the DMF)?  Company B think they don't have to register because they are not the manufacturer even though they are the holder/owner of the DMF.

Per the FD&C Act, looks like company A should list it...
"Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. These domestic and foreign firms must at the time of registration, list all drugs manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S."

Any thoughts? Comments?

Thank you for you help!