Drug Product
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Company Overview
About
53 Biologics is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Spain
Founded:2014
Employees:643
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
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 6CUIVP
EMA · #APR-8G82QTT4 · 2022-06-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ZOKIP7PL
Issued: 2020-04-02
Expires: 2025-06-13
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-FELPJ825
Issued: 2020-02-14
Expires: 2025-09-24
WHO GMP
World Health Organization
Cert #: CERT-EZGW1QW9
Issued: 2020-09-12
Expires: 2025-12-16
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Key facts about 53 Biologics
- 53 Biologics is headquartered in Spain.
- 53 Biologics was founded in 2014.
- 53 Biologics has 643 employees.
- 53 Biologics's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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