Regulatory Open Forum

Hi Forum,

Should the names of the suppliers of excipients be provided in NDA/BLAs? Is there a different expectation for suppliers of compendial excipients vs non-compendial excipients? If any should be provided, in which section should they be stated?

Since FDA Guidance for Industry Changes to an Approved NDA or ANDA Questions and Answers states in Q11 under Manufacturing Sites that CDER need not be notified of a change to a different manufacturing site for an excipient, does this imply that the names of the suppliers/sites do not need to be included in the application?

Thank you in advance for your response.

You don't need to include names of the suppliers of excipients which are designated compendial, USP, NF or EU etc. Non compendial you need to provide their composition, process, etc or LOA to DMF.