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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.

Synthetic chemistry infrastructure

Services

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

AuthorityIdentifierSource
FDAcGMP inspectionView
HPRAcGMP inspection (mutually recognised by FDA)View
PMDAProject specific inspectionView
ANVISAProject specific inspectionView
MHRAcGMP inspectionView
DEASchedule I-V controlled substances approvalView
ISOISO/IEC 27001:2022, ISO/IEC 9001:2015, ISO 45001:2018, ISO 14001:2015View
FDAcGMP inspection January 2017View
PMDAproject specific inspection June 2022View
HPRAcGMP inspection March 2022View
ANVISAproject specific inspection 2021View
MHRAcGMP inspection June 2021View
FDAcGMP inspection May 2018View
MHRAcGMP inspection April 2023View
FDARegistered as bulk API manufacturerView
DEAApproved to import, store, manufacture and export Schedule I-V controlled substancesView
FDAcGMP inspection March 2024View
cGMPcGMP accreditationView

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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