API & Intermediates Manufacturing | Contract Manufacturing

Established Specialists in Active PharmaceuticaI Ingredients Manufacturing

IDT Australia’s core strength is the synthesis of Active Pharmaceutical Ingredients (APIs) and their intermediates in a cGMP compliant environment. Our capabilities encompass process development and scale-up, ranging from milligram to kilogram scale. We specialise in handling high-potency and cytotoxic materials in our modular facilities, ensuring the safety of our products and personnel.

Manufacture of Active Pharmaceutical Ingredients (APIs) for human administration and API intermediates under cGMP by chemical synthesis or natural product extraction.
Manufacture at any stage of the pharmaceutical life-cycle from active substances for human clinical trials to commercial manufacture of registered therapeutics.
Capacity to grow as your clinical lead progresses through clinical trials to commercial registration with manufacturing from milligram to kilogram scale.
Modular facilities support manufacture of low-potency therapeutics to high potency, or antineoplastic (cytotoxic) agents.
Regulatory Authorisations: Includes: Australia (veterinary (APVMA) and human, US, Europe, and Japan.
Chemistry, analytical and microbiology facilities for release testing and conduct of stability trials in-house.

Technical Transfer

Do you need to establish a secondary supplier to reduce supply chain risk, or does your current vendor lack the capability to support your product to the next stage of its life-cycle?

Transfer of cGMP processes from other vendors to IDT’s facilities at any stage of the clinical or commercial life-cycle.
Transfer of analytical methods to our in-house analytical team.

Clinical Supply - from Benchtop to cGMP Supply

IDT Australia has extensive experience supporting the development of new chemical entities and bringing investigational drugs into pre-clinical and clinical studies. Using a phase-appropriate, risk-based approach, our services include:

Conversion of bench-scale chemistry to scalable, plant processes.
Process development to optimise bench-scale chemistry for cGMP manufacture.
Non-GMP/GLP manufacture of materials for pre-clinical investigations, including toxicology studies in small animals and indicative stability studies.
Development and validation of analytical methods to cGMP standards.
Identification of related substances (impurities) and preparation of analytical standards.
Specialty Orals / Advanced Therapies.
GMP manufacture for human trials.
Support preparation of CMC packages for regulatory submissions.

Antibody–Drug Conjugates (ADCs): Linker–Payload Manufacture

IDT Australia supports the rapidly growing field of targeted oncology by providing development and GMP manufacture. Leveraging our high-potency, modular manufacturing suites and extensive small-molecule expertise, we produce cytotoxic payloads, linkers, and the linker–payload intermediates essential to modern antibody–drug conjugates (ADC) therapeutics.

View our Linker Catalogue

Commercial Supply

IDT Australia holds multiple US Drug Master Files (DMFs) for a range of active pharmaceutical ingredients. Our current DMF includes:

Hematoporphyrin Diacetrate DMF# 14839
Mitoxantrone Hydrochloride DMF# 12328
Thiotepa DMF# 14170
Acetazolamide DMF# 12997
Minocycline Hydrochloride DMF# 15014

In addition IDT have developed synthetic procedures to manufacture:

Cisplatin Cas# 15663-27-1
Carboplatin Cas# 41575-94-4
Fentanyl Cas# 437-38-7
Schedule 8-9 Psychedelics and medicinal cannabis

Why Partner with IDT Australia for API Manufacturing

IDT Australia offers end-to-end Active Pharmaceutical Ingredients (API) development and manufacturing solutions with a focus on quality, compliance, and reliability. Our clients benefit from:

Only API CDMO in Australia: We are the only fully integrated, cGMP-compliant API contract development and manufacturing organisation based in Australia.
Full life-cycle support: From pre-clinical benchtop chemistry to commercial-scale production, we support your product at every stage of its life-cycle.
High-potency and cytotoxic expertise: Modular facilities allow safe handling and manufacture of low- to high-potency APIs, including antineoplastic agents.
Flexible manufacturing scales: Production ranges from milligrams to kilograms, enabling seamless scale-up.

API and Intermediates