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Contract Manufacturing Services

 

Trusted Pharmaceutical Manufacturing Services in Melbourne

We specialize in the manufacture of high containment, high potency Active Pharmaceutical Ingredients (HPAPI) and Finished Dose Form (FDF) production in a full cGMP environment.
Our FDF capabilities includes manufacture of sterile injectables as well as emerging advanced therapies like encapsulation of mRNA and conjugation of Antibody Drug Conjugates (ADCs)

We provide a comprehensive range of contract development and manufacturing (CDMO) services, working collaboratively with pharmaceutical partners to manufacture APIs and finished dose medicines for both local and global markets including clinical supply.

Find out how IDT Australia can support your next project

IDT Australia operates a cGMP manufacturing facility in Victoria. Our facility includes high containment and high potency manufacturing suites accommodating active pharmaceutical production from milligrams through to large-scale commercial projects. We also specialise in the manufacture of finished dose forms for pre-clinical and clinical trials (Phase I – Phase III), including:

  • Solid dose oral.
  • Liquid dose oral.
  • Sterile injectables.

Our cGMP analytical laboratory is fully equipped to provide a comprehensive range of services, as follows:

  • Finished Product Method development and validation.
  • Analytical technology transfer.
  • QC and Microbial testing for raw materials and finished products.
  • Stability assessment of products manufactured under all ICH conditions.

IDT Australia manufactures pharmaceuticals in a cGMP environment. Our facility has been audited and accredited by the Australian Therapeutic Goods Administration, the U.S. Food and Drug Administration, and the Japanese Ministry for Health Labour and Welfare. Our status as a high quality GMP manufacturer  extends to Europe and Canada via The Mutual Recognition Agreement. The facility holds S8 and S9 licensure, which underpins our medicinal cannabis extraction and finished product portfolio, as well as the development and manufacture of psychedelic materials for clinical trials.

HPAPI Manufacturing and Vertical Integration for Rapid Material Supply

IDT has built a solid reputation comprehensively integrating containment measures across every stage of development, providing HPAPI handling and containment services from API development through to commercial manufacturing

As a pharmaceutical API manufacturer, our focus is the manufacture of specialty APIs and integrating them into finished dose forms.
This vertical integration occurs on the same site and under the same quality system, providing a streamlined and efficient process for our clients. This " end-to end," holistic approach ensures a speedy supply of clinical materials, creating efficiencies for project timelines and reducing the effort associated with multiple tech transfers.
Our API team consists of professionals who have experience in working with a diverse range of synthetic processes and are supported by analytical and quality professionals from large pharmaceutical companies, who operate within a small biotech envelope. This allows us to combine the best of both worlds: the expertise of a large pharma company, with the agility and flexibility of a smaller organisation. With our capabilities and expertise, we're committed to delivering the highest quality products and services to our clients.

  • Experts in manufacturing specialty APIs.
  • Integrating APIs into finished doses on-site under a single quality system.
  • Streamlined and efficient development process based on Quality by Design principles.
  • Wholistic approach to development, ensuring for a speedy supply of clinical materials.
  • Combining large pharma expertise with small organisation flexibility.
  • Committed to delivering the highest quality products and services to our clients.

Medicinal Cannabis & Psychedelics (Processing, Extraction & Finished dosage forms)

IDT Australia is dedicated to staying at the forefront of the industry and providing cutting-edge solutions to our clients. That's why our cGMP manufacturing facility is fully accredited to offer medicinal cannabis processing and extraction up to a tonnage scale, including conversion to finished dosage forms. This places us in a leading position within the medicinal cannabis manufacturing space.

We also support manufacture of psychedelic APIs and finished dosage forms that are designed within the scope of recent regulatory guidance to ensure our clients requirements continue to be met as the demand for these emerging therapies increases.

Our facility is equipped with state-of-the-art technology and staffed by experienced professionals who are committed to ensuring the highest standards of quality and regulatory compliance. This allows us to provide our clients with a full range of services, from processing and extraction to the production of finished dosage forms. With our expertise and capabilities, we're able to meet the unique needs of our clients in the medicinal cannabis space and help bring their products to market as efficiently and effectively as possible.

Find out how IDT Australia can support your next project

Contact IDT Australia

If you’re looking for quality, turnkey cGMP contract manufacturing services, please get in touch with us today.