Cognate BioServices
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Advanced Modalities
Clinical Trial Supply & Logistics
Company Overview
About
Cognate BioServices is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:United States
Founded:2015
Employees:376
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval 4B6TN1
Health Canada · #APR-892LC6I6 · 2021-11-01
Drug Approval P94V6P
PMDA · #APR-TJXSL40X · 2022-07-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-RMWRVAWL
Issued: 2020-09-01
Expires: 2025-04-01
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-K5ETU52I
Issued: 2020-06-04
Expires: 2025-01-10
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-NJKW3IL2
Issued: 2020-09-14
Expires: 2025-08-03
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-9YVDYR72
Issued: 2020-11-26
Expires: 2025-04-09
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Key facts about Cognate BioServices
- Cognate BioServices is headquartered in the United States.
- Cognate BioServices was founded in 2015.
- Cognate BioServices has 376 employees.
- Cognate BioServices's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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