Bayer Contract Manufacturing
Leverkusen, Germany
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
○ Press
✓ EMA GMP (3)
○ MHRA GMP
✓ HC GMP (20)
Quick Facts: Bayer Contract Manufacturing
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Leverkusen, Germany
- Website
- https://www.bayer.com/en/portfolio/pharmaceuticals/contract-manufacturing
- Modalities
- Oral Solid Dose, Non-sterile Liquids, Semi-solids & Liquids, Sterile Injectables, Lyophilization, Prefilled Syringes, Small Molecule API, High-Potency APIs, Microbial Fermentation
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Bayer Contract Manufacturing
Bayer Contract Manufacturing makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Oral Solid Dose, Non-sterile Liquids, Semi-solids & Liquids, Sterile Injectables, Lyophilization, Prefilled Syringes, Small Molecule API, High-Potency APIs, Microbial Fermentation. 10 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.bayer.com/en/portfolio/pharmaceuticals/contract-manufacturing
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Bayer Contract Manufacturing FDA Inspection History
2024-06
2023-07
2022-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2024-06-19 |
Bayer Bitterfeld GmbH
Bitterfeld-Wolfen
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-07-20 |
Bayer Healthcare Manufacturing Srl
Garbagnate Milanese
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-11-24 |
Bayer Weimar GmbH und Co. KG
Weimar
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Bayer Contract Manufacturing EMA GMP Compliance 3 certificates
2026-03
2024-06
2019-04
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| IT/183/H/2026 | Bayer Healthcare Manufacturing S.r.l. | Italy | 2026-03-20 | COMPLIANT |
| DE_ST_01_GMP_2024_0027 | Bayer Bitterfeld GmbH | Germany | 2024-06-17 | COMPLIANT |
| IT-API/124/H/2019 | BAYER HEALTHCARE MANUFACTURING S.R.L. | Italy | 2019-04-19 | COMPLIANT |
Source: EMA EudraGMDP · 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. This company's careers site asks automated readers not to collect it (robots.txt), and we respect that.
Source:
public careers pages
· Checked Oct 30, 2026
Frequently Asked Questions About Bayer Contract Manufacturing
How many FDA inspections does Bayer Contract Manufacturing have on record?
CDMO Signal tracks 3 FDA inspections for Bayer Contract Manufacturing, sourced from the FDA inspection database. See the full inspection history above.
Has Bayer Contract Manufacturing received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Bayer Contract Manufacturing.
Does Bayer Contract Manufacturing hold EMA or MHRA GMP certificates?
CDMO Signal tracks 3 EMA GMP certificates for Bayer Contract Manufacturing.
Does Bayer Contract Manufacturing have a CDMO Signal Score?
Not yet. Bayer Contract Manufacturing is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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