How to choose a contract manufacturer in Australia: a checklist
A practical checklist for choosing a supplement or listed medicine contract manufacturer in Australia: licences, formats, run sizes, packing, quality records and communication.
The right contract manufacturer depends on your product, your volumes and how much help you need. Use this checklist when comparing options.
Licences and scope
For listed medicines, confirm the manufacturer holds a TGA GMP licence that covers your dosage form
For food-regulated supplements, ask which food safety certification applies
Ask for the scope in writing rather than relying on a website summary
Formats and equipment
Can they make your format: capsules, tablets, powders, sachets, liquids or creams?
Can they pack it in-house, or will the product move to a second site?
Run sizes
What is the minimum order for your format and pack?
Can the same product scale up later without changing manufacturer?
Quality and records
Will you receive batch records and release documentation?
How are deviations and complaints handled and reported to you?
Communication
Who is your day-to-day contact?
Can you visit the site and attend a trial run?
Talk to us
DB Pharmaceuticals is a TGA GMP licensed manufacturer in Kings Park, Sydney, focused on small to medium runs with packing on the same site. Send us your brief or call 02 9672 3222.
This guide is general information only. It is not regulatory or legal advice, and requirements change. Check current requirements with the TGA or a qualified regulatory consultant before making decisions about your product.