Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
Owens & Minor is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United States
Founded:2010
Employees:2,279
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Europe
Regulatory Approvals
Drug Approval 18WMQ1
EMA · #APR-YGKMVS9Q · 2020-03-01
Drug Approval A47X0K
PMDA · #APR-KZX50J2X · 2022-04-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-4952A0T9
Issued: 2020-09-11
Expires: 2025-10-01
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-SJG3KWQI
Issued: 2020-04-06
Expires: 2025-12-09
WHO GMP
World Health Organization
Cert #: CERT-FKR0IUWZ
Issued: 2020-03-18
Expires: 2025-11-20
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-SQ7LQSYW
Issued: 2020-03-21
Expires: 2025-04-18
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Key facts about Owens & Minor
- Owens & Minor is headquartered in the United States.
- Owens & Minor was founded in 2010.
- Owens & Minor has 2,279 employees.
- Owens & Minor's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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