Track Record in Small Molecule Development
Fully integrated CMC services boasts a proven track record of over 100 clients. With over 20 IND & Generic DMF Filings, our team has deep experience in complex Sugar Chemistry & heterocyclic compound manufacturing.
Track Record in Small Molecule Development
Client | Status | Largest Single Volume | Clinical Phase | BioDuro-Sundia Services |
---|---|---|---|---|
US | Rare Disease | 8 kg | Phase III | Providing GMP starting material |
Korea | Lung Cancer | 1500 kg | Phase III | Providing GMP starting material |
Korea | Rare Disease | 100 kg | Phase III | Providing GMP starting material |
US | Oncology | 20 kg | Phase II/III | API Production |
Korea | Inflammatory Disease | 10 kg | Phase II | API Production |
Canada | Breast Cancer | 30 kg | Phase I | API Production |
EU | Pain | 7 kg | Phase I | API process develop & providing GMP |
UK | Undisclosed | 200 kg | Phase I | GMP Intermediate/RSM for API |
China | Anti-HIV | 20 kg | Phase I | API Production |
China | Oncology | 30 kg | Phase I | Providing GMP starting material |
China | Antilipemic | 10 kg | Phase I | API Production |
China | Lung Cancer | 10 kg | Phase I | API Production |
China | Oncology | 5 kg | Phase I | API Production |
US | Oncology | 5 kg | PCD | API Production |
US | Oncology | 150 kg | PCD | Providing GMP starting material |
Korea | Oncology | 20 kg | PCD | Providing GMP starting material |
Korea | Antibiotics | 5 kg | PCD | Providing GMP starting materials |
Australia | Undisclosed | 10 kg | PCD | GMP intermediate/RSM for API |
China | Oncology | 100kg | PCD | Providing GMP starting material |
Taiwan | Periodic Paralysis | 2 kg | PCD | API Production |
Japan | Undisclosed | 500 kg | N/A | GMP Intermediate/RSM for API |
Japan | Undisclosed | 40 kg | N/A | GMP intermediate/RSM for API |
IND Filing Projects:
Classification | Pharmacology | Indications |
---|---|---|
Chemical Drug 1.1 | RR inhibitor | Cancer |
Chemical Drug 1.1 | Multi targeted RTK inhibitor | Cancer |
Macular degeneration | ||
Herbal Medicine 5 | Non hormones | Endometriosis |
Chemical Drug 1.5 | Prescription | Common cold |
Chemical Drug 1.1 | NP inhibitor | Cancer |
Chemical Drug 1.1 | Neuroprotectant | Stroke |
Chemical Drug 1.1 | ALK/MET inhibitor | Cancer |
Chemical Drug 1.1 | LDLR regulator | Hyperlipoidemia |
Chemical Drug 1.1 | Multi targeted RTK inhibitor | Cancer |
Chemical Drug 1.1 | b-RAF inhibitor | Cancer |
Chemical Drug 1.1 | Protease inhibitor | Cancer |
Chemical Drug 1.1 | mTOR inhibitor | Cancer |
Chemical Drug 1.1 | NS3-4A Protease inhibitor | HCV |
Chemical Drug 1.1 | Multi targeted RTK inhibitor | Cancer |
Chemical Drug 1.1 | MEK inhibitor | Cancer |
Chemical Drug 1.1 | Pro drug | Leukemia |
Chemical Drug 1.1 | Multi targeted drug | Senile dementia |
Chemical Drug 1.1 | PARP inhibitor | Cancer |
Chemical Drug 1.1 | Peptide Pro drug | Cancer |
Chemical Drug 1.1 | Confidential | Diabetes |
Chemical Drug 1.1 | Confidential | Cancer |
Chemical Drug 1.1 | Antivirus | Confidential |
Chemical Drug 1.1 | Confidential | Cancer |