| Listed site | cdmo | cdmo |
|---|
| Summary | IDT Australia is a cGMP CDMO delivering end-to-end pharmaceutical development and manufacturing services from active pharmaceutical ingredients to finished dosage forms, with expertise in small molecule APIs, specialty orals, advanced therapies, and integrated regulatory support. | Integrated CRDMO offering discovery, development, and manufacturing services for small molecule NCE programs across 280+ global pharma and biotech clients. |
|---|
| Services | - HPAPI Manufacturing (High-Potency)
- Process Development
- Secondary Packaging & Labeling
- API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- ADC Payload & Linker Synthesis
- ADC (Antibody-Drug Conjugate) Manufacturing
- Formulation Development
- Oral Solid Dosage Manufacturing
- Sterile Fill-Finish & Aseptic Manufacturing
- Vial Filling
- Lyophilization (Freeze Drying)
- CMC Analytical Development
- Stability Testing & Storage
- Quality Control Testing
- Regulatory Affairs
- CMC Regulatory Submission Support
- Technology Transfer
| - CMC Analytical Development
- Process Development
- Stability Testing & Storage
- Technology Transfer
- API Synthesis & Manufacturing
- Small Molecule Development & Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- ADC Payload & Linker Synthesis
- Flow Chemistry & Continuous Manufacturing
- CMC Regulatory Submission Support
- Solid-State Chemistry & Polymorph Screening
- Formulation Development
- Quality Control Testing
|
|---|
| Modalities | - Small Molecule
- Antibody-Drug Conjugate (ADC)
- Radiopharmaceutical
| - Small Molecule
- Antibody-Drug Conjugate (ADC)
|
|---|
| Indications | - Neurology
- Metabolic
- Ophthalmology
| Data not yet provided. |
|---|
| Locations | | - Headquarters, India, India
- UK Office, UK, United Kingdom
- USA Office, USA, United States
- Boston Laboratory, Boston, Massachusetts, USA
- Headquarters, Hyderabad, Telangana, India
- Bidar Campus (Unit IV & VI), Bidar, Karnataka, India
- Boston, Boston, Massachusetts, USA
- UK Facility, United Kingdom
- UK Operations, United Kingdom
- Bidar Campus (API Manufacturing), Bidar, Karnataka, India
- Integrated R&D Campus, Hyderabad, Telangana, India
- Boston Area Site, Boston, Massachusetts, USA
|
|---|
| Certifications | Data not yet provided. | - USFDA · Identifier: 21 CFR Part 210 and 211
- EU · Identifier: EU cGMP guidelines
- TGA · Identifier: TGA guidelines
- India · Identifier: Schedule M (Indian cGMP standards)
- My Green Lab (MGL) · Identifier: Green Lab Certification (98%+ compliance score)
- BSE · Identifier: 544306
- NSE · Identifier: SAILIFE
|
|---|
| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
|---|