Australia APAC
FDF / DRUG PRODUCTS SERVICES API PROCESSING in APAC
Boronia, VIC, Australia
About the plant
IDT Australia is a cGMP end-to-end CDMO and manufactures small molecule API, and finished dose forms such as capsules, tablets, non-sterile liquids, and sterile injectables (fill and finish into vials). We can do pre-clinical to commercial stages of manufacturing.
https://en.idtaus.com.au/
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
- TGA (Australia GMP)
Activity
- Oral liquids and semisolids, Oral solids / OSD, Injectables, Bottles, Bulk, Oral solutions, Syrups, Oral foams, Tablets, Hard capsules, Fill&Finish, Small volume vials, FDF / DRUG PRODUCTS, SERVICES, API PROCESSING manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): N/A
- DEA: N/A
- BSL: N/A
- Therapeutic areas: (C) Cardiovascular system, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (V09-10) Radiopharmaceuticals
- Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), TGA (Australia)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Formulation mixing, Lyophilization, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, CMC regulatory support, IND (Investigational New Drug aplication) filing support
