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API & Intermediates


Established Specialists in API Manufacturing

IDT are leaders in synthesising active pharmaceutical ingredients (APTs) and their intermediates, strictly adhering to comprehensive cGMP guidelines. Our capabilities encompass process development and scale-up, ranging from milligram to kilogram scale, ensuring seamless transitions throughout.

We specialise in handling high-potency and cytotoxic materials, employing state-of-the-art containment measures to ensure optimal safety. As a trusted CDMO, we offer a comprehensive suite of services, collaborating closely with MMIC 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 is the sole remaining Australian-based API manufacturer, with a strong legacy of serving the pharmaceutical industry in Australia. Our unique value proposition lies in offering end-to-end integration, ensuring a seamless transition from API development to finished dose manufacture within a single facility. 

This consolidated approach eliminates the common challenges associated with multiple tech transfers across various sites and vendors, resulting in reduced delays. At IDT, we place utmost emphasis on efficiency and effectiveness, employing a comprehensive approach governed by a unified quality system.

Key Features:

  • Streamlined Production: Benefit from end-to-end oversight, from API development to finished dose manufacture, on a single site.
  • Consistent Quality: Our unified quality system ensures adherence to regulations, reducing risks and delays.
  • Experienced Chemists: Skilled and seasoned synthetic organic chemists with over 60 years of collective experience in drug design and process development.
  • Onsite Experts: Dedicated development chemists provide subject matter expertise, ensuring accurate and efficient manufacturing of critical molecules from the first attempt.

IDT prides itself on delivering exceptional service, expert knowledge, and reliable manufacturing solutions. Trust us to be your  go to partner in API manufacturing, integration, and quality assurance.

IDT Australia operates as a reputable pharmaceutical manufacturer in a strictly regulated cGMP environment. Our facility has successfully undergone comprehensive audits and received accreditation from key regulatory authorities, including the Australian Therapeutic Goods Administration, the U.S. Food and Drug Administration, and the Japanese Ministry for Health Labour and Welfare.

Additionally, our adherence to high-quality GMP standards extends to Europe and Canada through The Mutual Recognition Agreement. These certifications affirm our commitment to upholding stringent quality control measures and complying with international regulatory requirements for the development and manufacture of cytotoxic compounds.

Full-Spectrum API Manufacturer (CDMO)

The escalating demand for cancer treatments necessitates the utilisation of Highly Potent Active Pharmaceutical Ingredients (HPAPIs), which play a pivotal role in chemotherapies, especially combination therapies. 

IDT excels in supporting the entire lifecycle of crucial compounds, from the research stage to registration and market launch. With expertise in the production of generic HPAPIs and the synthesis of cytotoxic compounds, IDT ensures comprehensive assistance throughout the process.

As a trusted partner, IDT provides the following advantages:

  • HPAPI Specialisation: IDT's focus on generic HPAPI production enables efficient access to key compounds for cancer treatments, aiding therapy development.
  • Full Support: IDT offers end-to-end services from research to market launch, ensuring seamless coordination and efficient progression.
  • Cytotoxic Expertise: IDT's exclusive synthesis capabilities strengthen its position in fighting cancer, enabling innovative, life-saving treatments.

Leveraging IDT's specialised capabilities and comprehensive support, researchers and pharmaceutical companies can accelerate the development of cancer treatments, bringing hope to patients in need.

Contact IDT Australia

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