IDT Australia has the experience, expertise and the technology to manage all of your drug development and commercial production requirements.
Today our pharmaceutical manufacturing capabilities include:
- An audited and accredited 12,000m² site in Melbourne.
- A modular campus, designed to accommodate R&D activities through to commercial-scale API and FDF formulation and manufacture.
- Expertise in the synthesis of small molecules, supplemented by significant capabilities and experience in extraction and purification of botanically derived products at up to 4000L scale - capabilities which position us a prime-partner in the emerging medicinal cannabis industry.
- We can formulate and manufacture a range of FDF products, (tablets, capsules, lyophilised and sterile fill/finish) in accordance with ICH guidance under full cGMP.
- Our site is audited and accredited by the Australian Therapeutic Goods Administration, European Medicines Agency and the U.S. Food and Drug Administration. In addition, we are licensed to manufacture Medicinal Cannabis products (API and FDF) by the Department of Health, Office of Drug Control.
- Our manufacturing facilities are supported by in-house analytical method development, stability chambers, modern chemistry and microbiology quality control laboratories, and a robust quality assurance system.
|Small Molecule R&D and Commercial Scale API Synthesis
State of the art automated and modular 100L, 400L, 4000L facility, includes 2 x 4000L, 2 x 400L and 2 x 100L reactors and Rosenmund filter receiver/drier
|2000L facility equipped with 3x 2000L reactors, rotary driers and centrifuges
|400L facility equipped with 400L & 63L reactors alongside multiple distillation reactors and Nutsche filters
|250L facility equipped with 2x 250L, 2 x 63L reactors and distillation capability
|100L facility equipped with 2x 100L reactors
|50L pilot-scale suites
|Medicinal cannabis extraction capability
Bench-scale R&D laboratories
|Finished Dosage Form
|Tablets - 22,000 to 136,000 tablets per hour
|Capsules - 38,000 per hour
|Sterile liquid /lyophilisation, fill and finish facility – 3,000 (20mL) capacity
|Support manufacture of clinical investigational products under full cGMP
|Liquid fill (medicinal cannabis)