Richter-Helm / Gedeon Richter Biologics (Mammalian DP complement)
Budapest, Hungary
Program data pending ClinicalTrials.gov matching
60.0
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
✓ Press (1)
✓ EMA GMP (9)
○ MHRA GMP
Quick Facts: Richter-Helm / Gedeon Richter Biologics (Mammalian DP complement)
- Signal Score
- 60.0/100
- Quality Compliance
- Assessment pending
- Headquarters
- Budapest, Hungary
- Modalities
- Monoclonal Antibody, Recombinant Protein, Biosimilars, Fill-Finish, Mammalian Cell Culture
- 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-Helm / Gedeon Richter Biologics (Mammalian DP complement)
Auto-created by AI matchmaker. Data verification pending.
Signal Score & Pillar Breakdown
Quality Compliance
—
No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.
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
ModalitiesMonoclonal Antibody, Recombinant Protein, Biosimilars, Fill-Finish, Mammalian Cell Culture
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
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity
60.0
Broad modality coverage (5 modalities)
Source: SEC EDGAR, press monitoring, company profiles
Profile-based capacity assessment
Recent Press1 articles
Broad modality coverage (5 modalities)
Richter-Helm / Gedeon Richter Biologics (Mammalian DP complement) 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 11, 2026
Recent News 1 articles
Gedeon Richter : GM - Proposals - marketscreener.com
Gedeon Richter : GM - Proposals marketscreener.com
Frequently Asked Questions About Richter-Helm / Gedeon Richter Biologics (Mammalian DP complement)
Does Richter-Helm / Gedeon Richter Biologics (Mammalian DP complement) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 9 EMA GMP certificates for Richter-Helm / Gedeon Richter Biologics (Mammalian DP complement).
What is Richter-Helm / Gedeon Richter Biologics (Mammalian DP complement)'s CDMO Signal Score?
Richter-Helm / Gedeon Richter Biologics (Mammalian DP complement) has a Signal Score of 60/100, based on quality, operations, financial stability, and capacity data.
Evaluating Richter-Helm / Gedeon Richter Biologics (Mammalian DP complement) for a manufacturing program?
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