Almac
United Kingdom
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (4)
○ Clinical Trials
○ SEC Filings
✓ Press (11)
✓ EMA GMP (3)
✓ MHRA GMP (12)
✓ HC GMP (17)
Quick Facts: Almac
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- United Kingdom
- Website
- https://www.almacgroup.com/
- Modalities
- Small Molecule API, Oral Solid Dose, Packaging & Labeling
- Active Programs
- No ClinicalTrials.gov matches confirmed — 1 partnership signal in press (announcements, not verified)
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Almac
Almac is a contract development and manufacturing organization (CDMO). Capabilities: Small Molecule API, Oral Solid Dose, Packaging & Labeling. 3 manufacturing sites registered with the U.S. FDA, the UK MHRA and Health Canada. Website: https://www.almacgroup.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Almac FDA Inspection History
2025-11
2025-08
2025-05
2024-09
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-28 |
Almac Pharma Services Limited
Craigavon
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-08-22 |
Almac Pharma Services LLC
Audubon, Pennsylvania
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-05-08 |
Almac Sciences Limited
Craigavon
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-09-16 |
Almac Pharma Services Limited
Craigavon
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Almac FDA 483 Findings 9 observations · 2025-08-22 → 2025-11-28 ?
By subsystem
By severity
- 5 — Critical: 1
- 3 — Moderate: 2
- 2 — Minor: 6
- Repeat observations: 0
Most severe findings
-
Computer control of master formula records
"Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel."
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed."
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."
Almac EMA GMP Compliance 3 certificates
2019-11
2019-10
2019-03
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| UK MIA(IMP) 20782 Insp GMP/GDP/IMP 20782/15328-0017 | ALMAC PHARMA SERVICES LIMITED | United Kingdom (Northern Ireland) | 2019-11-18 | COMPLIANT |
| UK GMP 31890 Insp GMP/IMP 31890/16997281-0004 [V] | ALMAC SCIENCES LIMITED | United Kingdom (Northern Ireland) | 2019-10-10 | COMPLIANT |
| UK MIA(IMP) 31890 Insp GMP/IMP 31890/383321-0012 | ALMAC SCIENCES LIMITED | United Kingdom (Northern Ireland) | 2019-03-21 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
Almac MHRA GMP Compliance 12 certificates
2025-09
2025-09
2025-05
2025-05
2025-05
2025-02
2024-09
2024-09
2019-12
2019-12
2019-12
2009-05
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK MIA 20782 Insp GMP/IMP 20782/17799871-0011[H] | ALMAC PHARMA SERVICES LIMITED | LOUGHBOROUGH LE11 5RB | 2025-09-29 | COMPLIANT |
| UK MIA(IMP) 20782 Insp GMP/IMP 20782/17799871-0011[I] | ALMAC PHARMA SERVICES LIMITED | LOUGHBOROUGH LE11 5RB | 2025-09-29 | COMPLIANT |
| UK API 31890 Insp GMP 31890/383321-0022 | ALMAC SCIENCES LIMITED | CRAIGAVON BT63 5QD | 2025-05-07 | COMPLIANT |
| UK GMP 31890 Insp GMP/IMP 31890/16997281-0010 [H] | ALMAC SCIENCES LIMITED | CRAIGAVON BT63 5XA | 2025-05-07 | COMPLIANT |
| UK GMP 31890 Insp GMP/IMP 31890/16997281-0010 [V] | ALMAC SCIENCES LIMITED | CRAIGAVON BT63 5XA | 2025-05-07 | COMPLIANT |
| UK MIA(IMP) 31890 Insp IMP 31890/16997281-0005[I] | ALMAC SCIENCES LIMITED | CRAIGAVON BT63 5XA | 2025-02-06 | COMPLIANT |
| UK MIA 20782 Insp GMP 20782/15328-0020[H] | ALMAC PHARMA SERVICES LIMITED | CRAIGAVON BT63 5UA | 2024-09-16 | COMPLIANT |
| UK MIA(IMP) 20782 Insp GMP/GDP/IMP 20782/15328-0018[I] | ALMAC PHARMA SERVICES LIMITED | CRAIGAVON BT63 5UA | 2024-09-16 | COMPLIANT |
| UK API 31890 Insp GMP 31890/383321-0016 | ALMAC SCIENCES LIMITED | CRAIGAVON BT63 5QD | 2019-12-16 | COMPLIANT |
| UK API 31890 Insp GMP/GDP 31890/383321-0015 [H] | ALMAC SCIENCES LIMITED | CRAIGAVON BT63 5QD | 2019-12-16 | COMPLIANT |
| UK API 31890 Insp GMP/GDP 31890/383321-0015 [V] | ALMAC SCIENCES LIMITED | CRAIGAVON BT63 5QD | 2019-12-16 | COMPLIANT |
| UK API 31890 Insp GMP 31890/383321-0001 | ALMAC SCIENCES LIMITED | CRAIGAVON BT63 5QD | 2009-05-21 | 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.
CPHI Pharma Awards 2026 recognise Touchlight, SeraNovo and Almac among fifteen category winners in Milan - Manufacturing Chemist
CPHI Pharma Awards 2026 recognise Touchlight, SeraNovo and Almac among fifteen category winners in Milan Manufacturing Chemist
As many CDMOs battle post-pandemic sales downturn, Almac's revenue jumps amid global expansion push - Fierce Pharma
Newsmakers Q&A: Almac Group - Contract Pharma
Growing Almac boosts capacity for manufacturing peptides and packaging commercial products - Fierce Pharma
Almac makes $48M commitment to eClinical offering with new trial coordinator platform - Fierce Biotech
CDMO Almac continues expansion spree with new £65M UK oral treatment plant - Fierce Pharma
Almac Group Unveils Latest GMP Facility - Pharmaceutical Commerce
Almac Group Grows Northern Ireland HQ, Welcomes New Facilities - Pharmaceutical Commerce
CDMO Almac continues its expansion momentum with lab deal - Fierce Pharma
Almac Pharma Services Expands Its Unique Ultra-Low Temperature Solutions for Advanced Therapy Medicinal Products - newswire.com
Almac Group extends personalised cancer vaccine production facilities - Express Pharma
Frequently Asked Questions About Almac
How many FDA inspections does Almac have on record?
CDMO Signal tracks 4 FDA inspections for Almac, sourced from the FDA inspection database. See the full inspection history above.
Has Almac received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Almac.
Does Almac hold EMA or MHRA GMP certificates?
CDMO Signal tracks 3 EMA and 12 MHRA GMP certificates for Almac.
Does Almac have a CDMO Signal Score?
Not yet. Almac is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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