
Description
Onyx Scientific is the CDMO division of Ipca Laboratories, offering small molecule drug substance development and manufacturing services. Our MHRA-licensed sites in the UK offer early development of candidate APIs and manufacturing for clinical phases through to commercial supply. Dedicated solid-state and analytical chemistry teams expedite development activities at Onyx but are also available to provide full-service outsourced projects to complement or support your in-house campaigns. With a wealth of early development experience and success, our pragmatic, fit-for-purpose approach focuses on rapid process development and a view to future GMP campaigns. Where required, scale-up through Phase II towards commercial manufacture is retained either at Onyx or within the Group through transfer to our sister sites and colleagues in the USA and India.
Type of Drugs Manufactured:
Small Molecule
CDMO Services:
Drug Substance Manufacturing (API);Research & Development;Regulatory Services;Analytical Development
No. of Manufacturing Facilities:
2
High Potent Products capabilities:
OEB 3
Facilities Locations:
Europe;North America;South Asia
Regulatory Approvals for facilities:
EMA (Europe);ISO;GMP
Manufacturing Technologies:
Liquids;Semi-solids;Solids
Capabilities
- Analytical Methods Development
- Analytical Services
- APIs (Active Pharmaceutical Ingredients)
- cGMP Synthesis
- Chemistry (CMC)
- Clinical Trial Materials
- Contract Development and Manufacturing (CDMO)
- Custom Synthesis
- Drug Substance Manufacturing (API)
- Medicinal
- Process Development
- Regulatory Services
- Research & Development
- Scale-Up
- Small Molecule