Regulatory Compliance
When it comes to regulatory compliance, IDT Australia has the world covered.
IDT operates as a reputable pharmaceutical manufacturer in a strictly regulated cGMP environment, with a focus on the development and manufacturing of oral finished doses. Our facility has successfully undergone comprehensive audits and received accreditation from established regulatory authorities, including:
- Australian Therapeutic Goods Administration (TGA)
- U.S. Food and Drug Administration (FDA)
- European through Mutual Recognition Agreement (MRA).
- Japanese Ministry for Health Labour and Welfare (JMHLW).
- Access to other markets through Mutual Recognition Agreements (MRA’s).
Additionally, our commitment to upholding high-quality GMP standards extends to Europe and Canada through The Mutual Recognition Agreement. These certifications validate our dedication to adhering to stringent quality control measures and complying with international regulatory requirements specific to the development and manufacture of oral finished doses.
IDT Australia hold the following licences:
Therapeutic Goods Administration⁺
GMP Certification and Licences to Manufacture Therapeutic Goods*
Department of Health Office of Drug Control
Medicinal Cannabis Manufacture Licence
Victorian Department of Health and Human Services
Licence to Manufacture and Sell or Supply by Wholesale Schedule 8 or Schedule 9 Poisons (other than heroin)
U.S. Food and Drug Administration
GMP (API and finished product)
- ⁺ Mutual Recognition Agreement (MRA) signed by Australia, European Union and Canada allows drug regulators to rely on their counterpart's GMP conformity assessments
- * Site licence includes packaging and processing of "dry herb material"