
Sterling Pharma Solutions
Partnership-driven small molecule CDMO with 50+ years of API development and manufacturing expertise.
Listed on cdmo.directory
Small molecule CDMO offering comprehensive API development and manufacturing from discovery through commercial cGMP production, with specialized expertise in complex and hazardous chemistries and ADC bioconjugation. Headquartered in Cork, Ireland.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Development (D)
Manufacturing (M)
Synthetic chemistry infrastructure
- Max chemical scale
- Commercial (>100 kg / tonne)
- Capabilities
- HPAPIDEA licensedFlow Chemistry
Regulatory clearances
Services
- API Synthesis & Manufacturing
- HPAPI Manufacturing (High-Potency)
- Controlled Substance Manufacturing
- Peptide Manufacturing
- ADC (Antibody-Drug Conjugate) Manufacturing
- ADC Payload & Linker Synthesis
- Flow Chemistry & Continuous Manufacturing
- Solid-State Chemistry & Polymorph Screening
- CMC Analytical Development
- Process Development
- CMC Regulatory Submission Support
- Bioconjugation Services
- Small Molecule Development & Manufacturing
- Quality Control Testing
- Technology Transfer
About this organization
Overview
Sterling Pharma Solutions is a partnership development and manufacturing organisation (PDMO®) with over 50 years of experience delivering small molecule API development and manufacturing solutions. The company serves biotechs and pharmaceutical companies across the entire product lifecycle, from early-stage discovery to full commercial roll-out.
Core Capabilities
API Development & Manufacturing: Comprehensive services spanning route scouting, design, process optimization, and clinical supply to commercial cGMP manufacturing. Capable of supporting projects from grammes to tonnes in-house.
ADC Development & Manufacturing: Dedicated bioconjugation team with years of experience supporting ADC projects from discovery and development through preclinical and clinical cGMP manufacture.
Lifecycle Support: Full-service capabilities across discovery, preclinical, Phase I, Phase II, Phase III, and commercial launch phases, with emphasis on process development, quality by design, design of experiments, and CMC regulatory support.
Differentiators
- Scientific Partnership Model: Transparent, collaborative approach emphasizing true partnership over transactional outsourcing
- Complex Chemistry Expertise: Significant experience with hazardous and complex chemical transformations
- Global Facility Network: Purpose-built facilities across UK, USA, and Europe with state-of-the-art equipment and cGMP accreditation
- Innovation Focus: Technology and Innovation Programme partnering with leading academic and technological institutions to apply emerging technologies
- Specialized Teams: Over 1,350 team members with expertise in chemistry, biology, process design, quality assurance, and engineering
Certifications
| Authority | Identifier | Source |
|---|---|---|
| FDA | cGMP inspection | View |
| HPRA | cGMP inspection (mutually recognised by FDA) | View |
| PMDA | Project specific inspection | View |
| ANVISA | Project specific inspection | View |
| MHRA | cGMP inspection | View |
| DEA | Schedule I-V controlled substances approval | View |
| ISO | ISO/IEC 27001:2022, ISO/IEC 9001:2015, ISO 45001:2018, ISO 14001:2015 | View |
| FDA | cGMP inspection January 2017 | View |
| PMDA | project specific inspection June 2022 | View |
| HPRA | cGMP inspection March 2022 | View |
| ANVISA | project specific inspection 2021 | View |
| MHRA | cGMP inspection June 2021 | View |
| FDA | cGMP inspection May 2018 | View |
| MHRA | cGMP inspection April 2023 | View |
| FDA | Registered as bulk API manufacturer | View |
| DEA | Approved to import, store, manufacture and export Schedule I-V controlled substances | View |
| FDA | cGMP inspection March 2024 | View |
| cGMP | cGMP accreditation | View |
Locations
Cork
Cork · Munster · Ireland
Cramlington
Cramlington · Northumberland · United Kingdom
Deeside
Deeside · Wales · United Kingdom
Newcastle Biosphere
Newcastle · Tyne and Wear · United Kingdom
North Carolina
North Carolina · North Carolina · United States
Wisconsin
Wisconsin · Wisconsin · United States
North Carolina
North Carolina · North Carolina · US
Wisconsin
Wisconsin · Wisconsin · US
Newcastle Biosphere
Newcastle · England · UK
North Carolina
North Carolina · US
Wisconsin
Wisconsin · US
Cramlington
Cramlington · England · UK
North Carolina
North Carolina · North Carolina · USA
Wisconsin
Wisconsin · Wisconsin · USA
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