Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
HydRegen Limited is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:United Kingdom
Founded:1997
Employees:2,807
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Global
Regulatory Approvals
Drug Approval M683H7
PMDA · #APR-XN54IX61 · 2018-03-01
Drug Approval OXDQGU
Health Canada · #APR-CZEA8YR8 · 2022-10-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-SY2ZH5KW
Issued: 2020-01-01
Expires: 2025-01-18
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-N9P0CPHZ
Issued: 2020-12-03
Expires: 2025-10-05
WHO GMP
World Health Organization
Cert #: CERT-YECDMQ7E
Issued: 2020-10-15
Expires: 2025-12-15
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Key facts about HydRegen Limited
- HydRegen Limited is headquartered in the United Kingdom.
- HydRegen Limited was founded in 1997.
- HydRegen Limited has 2,807 employees.
- HydRegen Limited's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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