API & Intermediates

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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.

Regulatory Compliance

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.

End to End Product Development

As a distinguished pharmaceutical CDMO, IDT has a proven record of accomplishment in the development and manufacturing of APIs and cytotoxic compounds. Our expertise encompasses a wide range of projects, from optimising APIs for early-stage clinical programs to large-scale production of finished dosage forms.

We take immense pride in offering comprehensive end-to-end services for the development and production of investigational medicinal products. With our extensive experience, technical proficiency, and scalable capabilities, we are the ideal partner for your clinical or preclinical projects.
From initial research and development to the production of investigational APIs, and ultimately manufacturing finished dosage forms for clinical trials, we provide seamless support throughout the entire process. All of this is conducted within a single site, under a unified quality system, ensuring efficient and reliable outcomes for your project.

In-House Method Development

Our in-house method development capabilities provide our team with convenient access to necessary resources and expertise, enhancing efficiency and reducing project timelines. This integration allows us to conduct method development alongside process development activities, ensuring the suitability and effectiveness of methods before validation. This integrated and holistic approach offers significant benefits to later-stage clinical projects.

IDT is committed to upholding stringent quality and regulatory standards and our team operates within a full cGMP environment. Through the internal integration of analytical services, we streamline manufacturing processes, ensuring a seamless experience for our clients and eliminating the necessity of external tech transfers to analytical or formulation providers. This comprehensive approach allows us to maintain control over the entire development process, ensuring optimal quality and minimising unnecessary complexities for our clients.

Quality by Design

IDT is dedicated to meeting the needs of our clients as a pharmaceutical CDMO by delivering high-quality products. Our development program and Tech Transfer process are based on Quality by Design (QbD) principles, focusing on developing and fulfilling the requirements of a Quality Target Product Profile (QTPP). This approach ensures that all development activities prioritise efficient experimental design and employ a risk management-based approach.

As a result, our APIs and finished dosage forms are optimised to surpass the product specifications outlined in the QTPP, guaranteeing that quality is instilled from the outset. Our program generates submission-ready data and documents, expediting the product development and registration process.
At IDT, we recognise the significance of speed to market, which is why we remain committed to delivering products that meet the highest quality standards promptly and efficiently. With our QbD program, we uphold this commitment, providing our clients with an exceptional experience.

Strong Global Network Specialising in API Development

As a trusted CDMO, IDT prioritises rapid drug formulation, process optimisation, and minimising trial delays. One of the ways these goals are achieved is through our strong collaborations with product development specialists in Melbourne and around the world, providing access to advanced research, development expertise and state-of-the-art tools.

These collaborations enable the efficient optimisation of process chemistry and drug product formulations. In other words, by leveraging international expertise and minimising trial and error experimentation, we effectively reduce delays and accelerate product development.

Our collaborative approach ensures the best possible outcomes for our clients in 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.