News: IMC Immuron Says FY23 Sales Increase 136% On Fy22 Sales, page-3

They need GMP Clearance from the TGA.

From the announcement:
"While Immuron does have inventory of Travelan® Australia ready to release, it is unable to do so until it has received GMP Clearance from the Therapeutic Goods Administration (TGA). Even though Immuron has transferred and validated the transfer of packaging to another supplier which has a valid/current GMP certificate from the TGA, the TGA is unable to give Immuron a timeline for GMP Clearance. The TGA advises that it is experiencing extremely high volumes of GMP Clearance extension applications which is resulting in delays to processing timeframes. Immuron shall continue to press for an early resolution of this issuewith the TGA."