List of licensed manufacturers in Australia

How to find an Australian licensed manufacturer in the TGA eBusiness Services (TBS) database

A list of Australian manufacturers that hold a current TGA licence can be found on the TGA Business Services databases (under ‘Public TGA Information’ in the left-hand navigation menu). Manufacturers are approved for specific steps of manufacture, and this information is available by selecting the ‘Australian Approved Manufacturer’ (see image below).

You can search for manufacturers by name or you can refine your search parameters by utilising the dropdown menus and free text box as displayed in the image below.

An example of a refined search is provided here. To search for a list of compounding manufacturers for example, select: All Manufacturers on the ‘Manufacturer:’ dropdown menu and Manufacturer Product Code on the ‘Filter on’ dropdown menu, and within the ‘for’ free text box, enter compounded. A list of relevant manufacturers will then be provided.

How to find suspended or revoked licences published in the Government Gazette

The following links will display lists of published decisions in the Government Gazette relating to licences to manufacture therapeutic goods, as recorded on the Federal Register of Legislation:

• Publication of List of Manufacturers Granted a Licence for the Manufacture of Therapeutic Goods.
• Publication of List of Manufacturers Suspended Licence for the Manufacture of Therapeutic Goods.
• Publication of List of Manufacturers Revoked Licence for the Manufacture of Therapeutic Goods.

To search for published decisions in the Government Gazette relating to a specific licence to manufacture therapeutic goods, as recorded on the Federal Register of Legislation, please follow these instructions:

1. go to Home Page - Federal Register of Legislation;
2. set the ‘search in’ filter to be “name and text”;
3. set the ‘search using’ filter to be “contains phrase”; and
4. use the ‘search for’ free text box and enter either the manufacturer’s name, site address or licence number.

The published decisions will use one of the naming conventions listed below:

• Publication of List of Manufacturers Granted a Licence for the Manufacture of Therapeutic Goods.
• Publication of List of Manufacturers Suspended Licence for the Manufacture of Therapeutic Goods.
• Publication of List of Manufacturers Revoked Licence for the Manufacture of Therapeutic Goods.

Please note that this search function is only applicable to decisions made from October 2012 onwards.

Decisions made prior to October 2012 can be accessed on the Federal Register of Legislation at Gazettes - Federal Register of Legislation.