Drug Product
Analytical & Bioanalytical Services
Qualification/Validation Services
Company Overview
About
COMSER (Comser Pharma) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Spain
Founded:2003
Employees:1,544
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval ICYLGD
FDA · #APR-RJP49UWA · 2019-05-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-N3BQC38L
Issued: 2020-10-08
Expires: 2025-04-02
WHO GMP
World Health Organization
Cert #: CERT-1K8GDXOQ
Issued: 2020-02-23
Expires: 2025-05-06
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-EVGUYS21
Issued: 2020-08-20
Expires: 2025-01-01
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Key facts about COMSER (Comser Pharma)
- COMSER (Comser Pharma) is headquartered in Spain.
- COMSER (Comser Pharma) was founded in 2003.
- COMSER (Comser Pharma) has 1,544 employees.
- COMSER (Comser Pharma)'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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