Sterling Pharma Solutions

Cramlington, United Kingdom
Small Molecule API High-Potency APIs Peptides ADC / Bioconjugation Controlled Substances Clinical Trial Manufacturing
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3) ○ Clinical Trials ○ SEC Filings ✓ Press (11) ✓ EMA GMP (1) ✓ MHRA GMP (2) ✓ HC GMP (13)

Quick Facts: Sterling Pharma Solutions

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Cramlington, United Kingdom
Website
Modalities
Small Molecule API, High-Potency APIs, Peptides, ADC / Bioconjugation, Controlled Substances, Clinical Trial Manufacturing
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Sterling Pharma Solutions

Sterling Pharma Solutions is a contract development and manufacturing organization (CDMO). Capabilities: Small Molecule API, High-Potency APIs, Peptides, ADC / Bioconjugation, Controlled Substances, Clinical Trial Manufacturing. 5 manufacturing sites registered with the U.S. FDA, the UK MHRA and Health Canada. Website: https://www.sterlingpharmasolutions.com/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

Sterling Pharma Solutions FDA Inspection History

2025-07
2024-03
2022-04
NAI VAI OAI
Date Site Type Observations Classification
2025-07-11
Sterling Pharma Solutions Ltd.
Cramlington Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2024-03-12
Sterling Wisconsin, LLC
Germantown, Wisconsin Company-level
Drug Quality Assurance No No Action Indicated (NAI)
2022-04-05
Sterling Pharma Ringaskiddy Limited
Ringaskiddy Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Sterling Pharma Solutions EMA GMP Compliance 1 certificates

2025-06
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
AUR25-039/ASR11450 Sterling Pharma Ringaskiddy Limited Ireland 2025-06-27 COMPLIANT
Source: EMA EudraGMDP · Retrieved Oct 31, 2026

Sterling Pharma Solutions MHRA GMP Compliance 2 certificates

2026-03
2025-07
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK MIA(IMP) 50416 Insp GMP/IMP 50416/18569221-0004[I] STERLING DEESIDE LIMITED DEESIDE CH5 2UA 2026-03-16 COMPLIANT
UK API 29350 Insp GMP 29350/292119-0008 STERLING PHARMA SOLUTIONS LIMITED CRAMLINGTON NE23 7QG 2025-07-08 COMPLIANT
Source: MHRA GMDP Database · Retrieved Oct 31, 2026

Hiring Activity Beta

Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source: public careers pages · Checked Oct 30, 2026

Company Signals 11 articles

Company announcements, not verified evidence. They do not change any score.
news Wed, 03 Ap
CDMO Sterling burnishes its U.S. credentials with buyout of North Carolina facility - Fierce Pharma
news Wed, 02 Ma
Novartis sells pair of manufacturing plants as Sandoz strategic review rolls on - Fierce Pharma
news Tue, 25 Ja
Sterling Pharma Solutions expands early phase development - Manufacturing Chemist
news Tue, 04 Oc
CDMO Sterling Pharma Solutions created from MBO of U.K. facility - Fierce Pharma
news Thu, 25 Ma
GHO Capital and Partners Group invest in Sterling Pharma - GlobeNewswire
news Thu, 13 Ju
The CDMO/CMO Report: High-Potency API Manufacturing - DCAT Value Chain Insights
news Thu, 08 Fe
ADC handling: the whole story of a facility startup - Cleanroom Technology
news Thu, 01 Oc
CDMO Sterling Pharma continues buying spree with former Alcami ingredients plant pickup - Fierce Pharma
news Fri, 31 Ma
Sterling Pharma Solutions to Invest $3 Million in Germantown, WI Plant - Pharmaceutical Commerce
news Fri, 17 Oc
Cabaletta corrals cell therapy Legend—Chutes & Ladders - Fierce Biotech
capacity 2026-10-06
Sterling Pharma Solutions doubles ADC manufacturing capacity at Deeside with new GMP suite - Manufacturing Chemist
Sterling Pharma Solutions doubles ADC manufacturing capacity at Deeside with new GMP suite  Manufacturing Chemist

Frequently Asked Questions About Sterling Pharma Solutions

How many FDA inspections does Sterling Pharma Solutions have on record?
CDMO Signal tracks 3 FDA inspections for Sterling Pharma Solutions, sourced from the FDA inspection database. See the full inspection history above.
Has Sterling Pharma Solutions received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Sterling Pharma Solutions.
Does Sterling Pharma Solutions hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 EMA and 2 MHRA GMP certificates for Sterling Pharma Solutions.
Does Sterling Pharma Solutions have a CDMO Signal Score?
Not yet. Sterling Pharma Solutions is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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