How to choose a supplement manufacturer in Australia

Why the licence comes first

A brand that arranges for another business to make its medicine is, in the law's words, its sponsor, and it is the sponsor's job to make sure every step is made by someone allowed to make it. The TGA puts the rule plainly: it is an offence, carrying heavy penalties, to manufacture therapeutic goods for human use without a licence unless the manufacturer or goods are exempt.

The law reads "manufacture" broadly. It covers producing the goods and any part of the process of bringing them to their final state: processing, assembling, packaging, labelling, storage, testing and releasing for supply. So the business that packs and labels your product, the laboratory that tests your batch and the person who releases it are all manufacturers in the law's sense, and each must hold, or work under, the licence or clearance for what it does.

Only Australian sites can hold a TGA manufacturing licence. The standard a licensed site making medicines meets is the PIC/S Guide to GMP, version PE009-17, which has applied since 1 September 2025; for manufacturers of non-sterile medicines, the TGA says that update made no material change.

What a licence covers, and how to check it

A TGA licence to manufacture states its number, its holder, its manufacturing sites and a description of the types of products and manufacturing steps it authorises. A schedule of conditions usually comes with it. A licence has no expiry date: it stays in force until it is revoked or suspended, and once it is, manufacturing, supplying or exporting from that site is an offence.

You can check a manufacturer yourself. The TGA's Australian Manufacturer search, in TGA Business Services under "Public TGA Information", lists the Australian manufacturers that hold a current licence, and the "Australian Approved Manufacturer" certificate attached to each result shows the steps it is approved for. Since October 2025 the TGA also publishes its decisions to grant, suspend or revoke licences on its website. Information about overseas manufacturers isn't public.

What to check is that the licence covers your dosage form, and that the certificate lists each step the manufacturer will carry out. A factory licensed to make tablets isn't thereby licensed to make softgels, and a factory that makes your capsules may not be the one licensed to release them.

Some goods and manufacturers are exempt from licensing under Schedules 7 and 8 of the Therapeutic Goods Regulations 1990. Herbs and herbal oils used only as starting materials by a licensed manufacturer are one example the TGA gives. Before accepting that a supplier needs no licence, check its exemption against the current Regulations.

The five steps every listing names

When a sponsor lists a medicine, it names the manufacturers and the steps each one carries out. Five steps are compulsory, and each must be covered by at least one manufacturer:

1. manufacture of the dosage form;
2. packaging and labelling;
3. release for supply;
4. testing: chemical and physical testing; and
5. testing: microbial testing.

One manufacturer can carry out several steps, and a step can be carried out by more than one. The TGA's listing system checks each manufacturer's licence or clearance for an exact match to the step, and won't validate the listing without one; the licence or clearance also designates the dosage form and product category, which the sponsor must check. The sponsor stays responsible for making sure each entry on the ARTG has at least one TGA-approved manufacturer, licensed or holding a current GMP clearance, for every step, release for supply included.

Changing or adding a manufacturer later is a variation of the medicine's ARTG entry.

Release for supply

Release for supply is the step at which a batch is certified for sale. It is a licensable step in Australia, carried out by an authorised person of a TGA-approved manufacturer, who certifies before release that each batch has been made and controlled in line with the medicine's marketing authorisation and the other regulations that apply. Under the GMP code, no batch is released for sale or supply before that certification.

A sponsor that wants to release its own batches must hold a TGA manufacturing licence for the step, be authorised for it in the listing and meet the responsibilities of a release-for-supply manufacturer. Release can be contracted out only to an authorised person who holds, or works under, a licence or a current GMP clearance that includes it. The sponsor still has responsibilities in release: it gives every manufacturer the requirements of the listing, and shares responsibility with them for the ability to recall a batch, the GMP agreements, ongoing stability data and product quality reviews.

The GMP agreement

The PIC/S Guide to GMP requires a written contract between the business that outsources a GMP activity, the contract giver, and the business that carries it out, the contract acceptor, which clearly sets out each party's roles and responsibilities. The TGA calls it a GMP agreement, and its guidance also speaks of GMP, quality or technical agreements; sponsors and manufacturers are required to have GMP agreements covering every partial manufacturer in the supply chain. Under Chapter 7 of the Guide:

• Before outsourcing, the contract giver assesses the legality, suitability and competence of the contract acceptor, and afterwards monitors and reviews its performance.
• The contract says which party is responsible for each step, from purchasing and testing materials to production and quality control, and the technical parts are drawn up by people who know GMP.
• The contract acceptor doesn't subcontract any of the work without the contract giver's prior evaluation and approval, and doesn't make unauthorised changes that could affect quality.
• The records, from manufacturing and analytical records to distribution records and reference samples, are kept by, or available to, the contract giver.
• The contract giver can audit the work, at the contract acceptor and at any subcontractor they have agreed.

For listed medicines, the TGA's stability guidance says the responsibilities for ongoing stability testing should be written into the GMP agreement, unless one business is the sponsor, the manufacturer and the releaser. In the TGA's words, a sponsor "cannot delegate responsibilities, but you can delegate certain tasks", and the tasks should be agreed in writing.

The standards each batch meets

TGO 101 is the standard for tablets, capsules and pills. Unless it follows an applicable monograph in the British, European or US pharmacopoeia, a listed tablet or capsule meets the order's own requirements:

• each active ingredient must assay at 90.0 to 120.0% of the content stated on the label, with different limits for vitamins, minerals, enzymes and probiotics;
• tablets and capsules that aren't chewable must pass a disintegration test, unless the order calls for a dissolution test instead;
• modified-release products, and most tablets and capsules with 100 micrograms or more of folic acid, have a dissolution test; and
• the order sets uniformity of weight and limits on elemental impurities.

TGO 100 sets the microbiological standards medicines must meet, with a few exceptions such as export-only medicines. A complementary medicine taken by mouth that contains raw material of natural origin, animal, vegetable or mineral, must meet the acceptance criteria in its Schedule 1 (a herbal tea made with boiling water meets Schedule 2 instead): limits on total aerobic microbes, yeasts and moulds and bile-tolerant gram-negative bacteria, and no Salmonella, E. coli or Staphylococcus aureus in the amount tested.

A medicine must comply with TGO 101 throughout its shelf life, but the TGA says not every test must be run on every batch: the design of the medicine, its control strategy and its validation or stability data can show the standard will be met. A sponsor may set release specifications tighter than the order.

Under the GMP code, a finished product's specification sets out its formula, its form and pack, the directions for sampling and testing, the acceptance limits, the storage conditions and the shelf life, and test results are formally assessed against it before a batch is released. A certificate of analysis summarises the results for a batch, with its evaluation against the stated specification. More on shelf life and the stability program in our stability testing guide.

A manufacturer overseas

An overseas manufacturer of a medicine supplied in Australia must meet the same standards and practices as an Australian one, but it can't hold a TGA licence. Instead, the Australian sponsor holds a TGA GMP clearance for each overseas site it uses, one per site, per sponsor, and should keep evidence of GMP compliance for each of them. After a successful TGA inspection, the manufacturer receives a GMP certificate, and the sponsor that applied, or contributed to the inspection's costs, receives the clearance.

For a listed medicine, a clearance often can't rest on another regulator's evidence. The TGA's guidance says this is often not possible for listed medicines, because of differences in regulatory frameworks and GMP standards, and that its reliance routes aren't intended for some complementary and listed medicines, which may not be regulated as medicines in other countries. That can mean a TGA inspection before the first batch. Apply to renew a clearance at least six months before it expires. The routes, the fees and the renewal rules are in our GMP clearance guide.

Food and cosmetics manufacturers

A supplement sold as a food has no TGA licence. Under Standard 3.2.2 of the Food Standards Code, a food business must notify its enforcement agency before it starts handling food, the people who handle food, or supervise its handling, must have skills and knowledge in food safety and hygiene suited to their work, and a manufacturer must have a written system for recalling unsafe food. Beyond that, state law decides: in NSW, a manufacturer whose main activity is manufacturing or wholesaling notifies the NSW Food Authority, unless it is in a sector the Authority licenses, such as dairy or meat, and the Authority sets how often it is inspected by its risk class; in Queensland, a food business that involves the manufacture of food needs a licence. Whether a product can be a food at all is on our food pathway page.

A cosmetic has no TGA licence either: the TGA doesn't regulate cosmetics. Cosmetic ingredients and products are controlled through AICIS, the ACCC, which is the primary regulator of cosmetic products, and the Poisons Standard. ISO 22716 is the international standard of good manufacturing practice guidelines for cosmetics, covering production, control, storage and shipment. A business that imports cosmetics or their ingredients, or manufactures industrial chemicals, must register with AICIS before it does; one that buys all its ingredients from Australian suppliers and only blends them doesn't need to. More on our skincare page and in our AICIS guide.

Questions to ask before you sign

1. Does your TGA licence cover our dosage form and every step you will carry out? May we see the Australian Approved Manufacturer certificate?
2. Who will carry out each of the five steps the listing needs, and will any step be subcontracted, and to whom?
3. Who will release each batch for supply, and under which licence?
4. When was your last TGA inspection, and what was its outcome? The TGA rates a site A1 (good), A2 (satisfactory) or A3 (basic), or unacceptable, and a better rating means a longer interval before the next inspection.
5. Will you sign a GMP agreement that sets out who does each step, keeps the records available to us and lets us audit?
6. What is the specification each batch is tested against, which tests run on every batch, and will we receive the certificate of analysis?
7. Who runs the ongoing stability program, and is it written into the agreement?
8. How will you tell us about deviations, complaints and anything that could lead to a recall?
9. For a site overseas: can the site be cleared for a listed medicine, does it need a TGA inspection, and who pays for it?
10. What are the minimum order, the unit price, the lead time and the payment terms?

Where we come in

Take Friday Off is not a contract manufacturer. We develop the product, then manage its manufacture through cGMP partners matched to its format, its volume and the margin it has to make. For a listed medicine, every step is made under the licence or clearance it needs, and every batch is third-party tested before release. From our records:

• A format that wouldn't run. An eye-health formula kept failing in encapsulation because the ingredient mix was too wet, and hand-filling would have added one to two more months. We moved it to a direct-compression tablet.
• A first run troubleshot with the maker. We managed manufacturing for every order of Arxi's preconception capsule, troubleshooting the first run with the maker, through to delivery.
• Reorders. BWellness has had five production batches since 2021, with imported ingredients, customs and freight managed through to its warehouse.

Our minimum run is 3,000 finished retail packs per batch, a production run takes 12 to 14 weeks once the specification is signed, and payment is 50% with the purchase order and 50% before dispatch. More on our manufacturing page.