Listed medicines
Listed medicine (AUST L) contract manufacturing
DB Pharmaceuticals is a TGA GMP-licensed contract manufacturer of listed medicines in Kings Park, Sydney. We make capsules, tablets, powders, liquids and creams for AUST L sponsors, with blister, bottle and sachet packing in-house. Capsule runs start from around 10,000 capsules, and typical lead times are 3 to 8 weeks once your formula is approved and materials are in stock. Large runs are also available.
How we manufacture listed medicines
Your product brief. You, as sponsor, provide the formulation and specification for your AUST L product.
Manufacturability review. We check the dosage form, pack format and run size.
Manufacture. Capsules, tablets, powders, liquids or creams are made under our TGA GMP licence.
Packing. Blister, bottle, sachet or tube packing, labelled in-house.
Review and release for supply. Each batch is documented. Its batch record, in-process checks and applicable test results are reviewed against the approved specification before release through our quality system.
Sponsor and manufacturer roles
The sponsor (brand owner) holds the ARTG listing and is responsible for the product’s ingredients, claims and labelling. DB Pharmaceuticals manufactures to the sponsor’s approved specification under our own TGA GMP licence. We don’t give regulatory advice. Read How to get a listed medicine manufactured in Australia.
Dosage forms
FAQ
Listed medicine FAQs
Are you TGA licensed?
Yes. DB Pharmaceuticals holds a TGA GMP manufacturing licence for its facility in Kings Park, Sydney.
What dosage forms do you make for listed medicines?
Capsules, tablets, powders and sachets, liquids, and creams and gels.
What is the minimum run for a listed medicine?
Capsule runs start from around 10,000 capsules. Minimums for tablets, powders, liquids and creams depend on the product and pack, and we confirm them with your quote. We specialise in small to medium runs, with large runs available.
How long does manufacturing take?
Typically 3 to 8 weeks once your formula is approved and raw materials are in stock. We confirm timing with your quote.
Do you pack listed medicines?
Yes, in blisters, bottles, sachets and tubes, labelled in-house.
Who holds the ARTG listing?
The sponsor (brand owner) holds the listing. We manufacture under our TGA GMP licence to your approved specification.
Will you help with my ARTG listing?
The listing is the sponsor’s responsibility. We provide the manufacturing information a sponsor normally needs from their manufacturer.
Do you manufacture registered (AUST R) medicines?
No. DB Pharmaceuticals manufactures listed medicines only.
Where are you located?
6 Coronation Ave, Kings Park NSW 2148, in Sydney. Call 02 9672 3222.