Richter BioLogics
Hamburg, Germany
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
82.9
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
✓ Press (1)
✓ EMA GMP (9)
○ MHRA GMP
Quick Facts: Richter BioLogics
- Signal Score
- 82.9/100 (as of 2026-04-29)
- Quality Compliance
- 100.0/100 — No FDA inspection records found for this manufacturer
- Headquarters
- Hamburg, Germany
- Modalities
- Plasmid DNA, Recombinant Proteins, VHH/Nanobodies, Bacterial Vaccines, Biologics
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Richter BioLogics
Pure-play microbial CDMO (est. 1987). 100% owned by Gedeon Richter since Sep 2024. Three cGMP sites in Germany: Hamburg (HQ, PD, analytical), Bovenau (10,000 m², up to 1,500L), Hannover (1,000 m², up to 300L). Specializes in E. coli and P. pastoris expression. Proprietary RB-pART pDNA platform. Approved by EMA, FDA, PMDA, ANVISA, Health Canada, MFDS. Tripled capacity in 2024 via EUR 95M Bovenau expansion.
Signal Score & Pillar Breakdown
Quality Compliance
100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
EMA GMP Certificates9 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesPlasmid DNA, Recombinant Proteins, VHH/Nanobodies, Bacterial Vaccines, Biologics
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
68.0
Parent company: Gedeon Richter
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Gedeon Richter
Financial assessment: 68.0/100
Capacity
68.0
3 manufacturing sites
Broad modality coverage (5 modalities)
Sites: Hamburg, DE, Bovenau, DE, Hannover, DE
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
Recent Press1 articles
3 manufacturing sites
Broad modality coverage (5 modalities)
Richter BioLogics EMA GMP Compliance 9 certificates
2025-11
2025-11
2025-02
2025-02
2022-06
2022-06
2022-06
2022-06
2017-06
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_NI_02_GMP_2025_0058 | Richter BioLogics GmbH | Germany | 2025-11-26 | COMPLIANT |
| DE_NI_02_GMP_2025_0057 | Richter BioLogics GmbH | Germany | 2025-11-26 | COMPLIANT |
| DE_SH_01_GMP_2025_0041 | Richter BioLogics GmbH | Germany | 2025-02-05 | COMPLIANT |
| DE_SH_01_GMP_2025_0040 | Richter BioLogics GmbH | Germany | 2025-02-05 | COMPLIANT |
| DE_SH_01_GMP_2022_0044 | Richter-Helm BioLogics GmbH & Co. KG | Germany | 2022-06-30 | COMPLIANT |
| DE_SH_01_GMP_2024_0044 | Richter-Helm BioLogics GmbH & Co. KG | Germany | 2022-06-30 | COMPLIANT |
| DE_SH_01_GMP_2024_0043 | Richter-Helm BioLogics GmbH & Co. KG | Germany | 2022-06-30 | COMPLIANT |
| DE_SH_01_GMP_2022_0043 | Richter-Helm BioLogics GmbH & Co. KG | Germany | 2022-06-30 | COMPLIANT |
| DE_SH_01_GMP_2017_1032 | Richter-Helm BioLogics GmbH & Co. KG | Germany | 2017-06-29 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Jul 04, 2026
Recent News 1 articles
Gedeon Richter : GM - Proposals - marketscreener.com
Gedeon Richter : GM - Proposals marketscreener.com
Frequently Asked Questions About Richter BioLogics
Does Richter BioLogics hold EMA or MHRA GMP certificates?
CDMO Signal tracks 9 EMA GMP certificates for Richter BioLogics.
What is Richter BioLogics's CDMO Signal Score?
Richter BioLogics has a Signal Score of 83/100, based on quality, operations, financial stability, and capacity data.
Evaluating Richter BioLogics for a manufacturing program?
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