Excipients & Specialty Ingredients
Regulatory, Tech Transfer & Support Services
Company Overview
About
Iris Biotech GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:Germany
Founded:1990
Employees:2,872
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
BSL-2 (Biosafety Level 2)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Europe
Regulatory Approvals
Drug Approval KQMWFS
EMA · #APR-T5XMR60K · 2022-09-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-X1PDEI45
Issued: 2020-04-27
Expires: 2025-12-15
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-3V7DO1KS
Issued: 2020-06-08
Expires: 2025-05-24
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-WXW2VYK8
Issued: 2020-09-23
Expires: 2025-10-04
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-11YSNXZL
Issued: 2020-01-23
Expires: 2025-01-18
Loading CDMO intelligence...
Key facts about Iris Biotech GmbH
- Iris Biotech GmbH is headquartered in Germany.
- Iris Biotech GmbH was founded in 1990.
- Iris Biotech GmbH has 2,872 employees.
- Iris Biotech GmbH's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
Find CDMOs like Iris Biotech GmbH
Directory pages this company appears in, each with the full list of matching manufacturers.