from api r&d to finished dose manufacture
IDT Pharma specialises in the development, scale-up, and cGMP clinical and commercial manufacture of high potency and cytotoxic API and finished drug product. Since 1975 we have gained extensive experience developing cytotoxics, anti-cancer drugs, antibiotics, beta lactams and controlled drugs. Our API facilities offer fully scalable processes from laboratory R&D to commercial scale using multistep chemical synthesis in both dedicated and flexible (ISO 8) manufacturing space streamlining your scale up pathway.
Oral finished dosage forms such as powders, hard gelatin capsules and film coated tablets are manufactured from small R&D and clinical trial scale through to commercial volumes in full containment suites and our state of the art, dedicated beta lactam commercial manufacturing facility can manufacture beta lactam API, tablets and sterile parenterals (lyophilisation) in vials.
Full analytical method development, validation and testing (including microbiology) of both API’s and finished dosage forms can be conducted in our high containment laboratories to enable analysis of highly toxic or highly potent products, along with stability testing under all ICH conditions.
IDT Australia also offers a comprehensive range of specialist clinical trial labelling, packaging and dispensing services and can manufacture, under cGMP, active and placebo clinical trial supplies in a wide variety of dosage forms, including tablets, coated tablets, capsules, suspensions, liquids, sprays, patches, lyophilised powders and ointments.
20-50 (x4), 60, 100 (x2), 250 and 400 litre
HEPA filtered air (in and out) ISO8
Closed system for equipment
Protection for operators
Non-containment 400 and 2000 litre reactors
Sterile lyophilised facility
High containment environment
Manufacture from small scale to commercial
Up to 85,000 units / hour
API and Finished Dosage Form development
Analytical method development
Dry blending / Wet granulation
Class A sterile filling room
Vial filling – 4,000 / hr, half or full
5mL – 100mL vials
3,000 20mL vial capacity
-55 to +80C
Sterile liquid, powder or lyophilized filling
Stability testing (ICH conditions)
Specific optical rotation
Uniformity of dosage
Hardness / Friability / Disintegration
Randomisation & blinding
Assembly of patient kits
Storage of clinical trial supplies (-20C, 2-8C, 15-25C)
Distribution to trial sites
Temperature controlled & cold chain logistics