SP
Sterling Pharma Solutions
CDMO · Cramlington, United Kingdom
GMP
Overview
Sterling Pharma Solutions develops and manufactures APIs for drug companies from preclinical work to commercial supply. Its Cork site, established in 1994, has three API manufacturing buildings, solid-phase and agitated vessels for peptide coupling and synthesis, and GMP manufacturing from 250 L to 10,000 L. Sterling says the Cork site has been inspected by the PMDA, HPRA, ANVISA, FDA and HSA. The group also runs API sites in Cramlington (UK), North Carolina and Wisconsin (US).
Capabilities
- GMP peptide API manufacture
- Solid-phase peptide synthesis
- Large-scale chromatography
- Technology transfer
- Lyophilisation and milling
Quality signals
| GMP evidence | Yes |
|---|---|
| Certificates of analysis | Not found |
| Third-party testing | Not found |
| ISO certification | Not found |
| Makes own product | Yes, in-house production |