IDT Australia Limited (ASX: IDT), founded in 1975 and headquartered in Boronia, Victoria, is a pharmaceutical manufacturing company with deep expertise in high-potency and high-containment drug products. The company operates cGMP-compliant facilities regularly audited by the US FDA and Australia’s TGA. IDT provides end-to-end services ranging from early drug development to commercial-scale manufacturing, specialising in active pharmaceutical ingredients and finished dosage forms, including oral and injectable medicines. Shares in IDT are currently trading at $0.10.
Under the agreement with Nacuity Pharmaceuticals Pty Ltd, IDT will produce NPI-001 (N-acetylcysteine amide), a novel therapy for patients with retinitis pigmentosa (RP)—a rare, progressive eye disease that leads to irreversible vision loss and currently lacks an approved treatment. The contract includes an initial $3.2 million statement of work, with the potential for additional annual contracts beyond the current scope.
NPI-001 has been granted Fast Track designation by the US Food and Drug Administration (FDA), underscoring its potential to address a serious unmet medical need. The program will involve scaling up the production of the drug’s active ingredient tenfold to approximately 200 kilograms and the manufacture of roughly one million tablets to support clinical development and potential commercial launch.
The project has already commenced, with manufacturing activities underway and scheduled for completion by the end of the 2026 financial year.
This contract has provided the catalyst for IDT to recommission its 4,000L Active Pharmaceutical Ingredient facility, which will now be the largest small molecule API plant in Australia. The facility’s capabilities offer not only a competitive advantage in the commercial manufacture of high-value therapies like NPI-001 but also provide strategic benefits for Australia’s pharmaceutical supply chain resilience.
By reviving this high-capacity facility, IDT strengthens its ability to address domestic drug shortages, support sovereign manufacturing, and respond to future healthcare needs, including potential stockpiling for emergency situations or public health responses.
Halden Conner, CEO of Nacuity Pharmaceuticals, cited IDT’s world-class facilities and proven track record as key factors in the decision to partner with the company. “Nacuity continues to invest in Australian innovation due to its globally respected R&D and clinical trial ecosystem. IDT’s ability to manage both development and large-scale production makes them an ideal partner for our program,” he said.
The agreement further demonstrates the global relevance of Australia’s pharmaceutical manufacturing sector and highlights IDT’s role as a preferred provider for international biotech firms seeking high-quality, scalable solutions.
This contract is a strong endorsement of IDT’s strategic direction and demonstrates the company’s ability to secure high-value, long-term manufacturing partnerships. With the 4,000L plant now operational and a growing pipeline of projects, IDT is well-positioned to pursue additional contracts across both domestic and international markets.
The recommissioning of its API facility also comes at a time when governments and healthcare providers are increasingly focused on securing local manufacturing capacity for essential medicines. IDT is expected to benefit from this shift as policymakers prioritise supply chain resilience and reduce reliance on offshore production.
With work on NPI-001 already underway and the potential for future expansion, IDT’s role in manufacturing next-generation therapies appears increasingly central to Australia’s pharmaceutical landscape. Investors will be watching for additional contract wins, further scale-up milestones, and potential commercial production opportunities stemming from this and similar projects.
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