A proven track record designing, developing, and manufacturing regulatory approved Active Pharmaceutical Ingredients (APIs) in Australia.
We are leaders in synthesizing active pharmaceutical ingredients (APIs) and their intermediates, strictly adhering to comprehensive cGMP guidelines including high-potency and cytotoxic materials by employing state-of-the-art containment measures to ensure optimal safety.
IDT Australia, with our facility in Melbourne, offers a safe and reliable partner to manufacture these most critical products. We have the capacity to quickly commence large scale production of APIs essential for lifesaving cancer treatments which can be finished on site or shipped to finish at external sites (including internationally).
We hold numerous drug master files for commercial APIs in Australian and global markets.
Our end-to-end integration ensures a seamless transition from API development to finished dose manufacture within a single facility.
Our capabilities encompass process development and scale-up, ranging from milligram to 1000 kilogram scale, ensuring seamless transitions throughout.
IDT has met with U.S. government officials to validate that this capability can help mitigate U.S. drug shortages, particularly in oncology and essential medicines. Refer to our Product Catalog for areas where we can ramp up quickly.