Drug Product
Analytical & Bioanalytical Services
Clinical Trial Supply & Logistics
Regulatory, Tech Transfer & Support Services
Company Overview
About
Astrea Pharma is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:France
Founded:1990
Employees:1,107
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
Clinical
Commercial Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Astrea Monts
18 Rue de Montbazon, Monts, 37260
Site Capabilities
4 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
Regulatory Approvals
Drug Approval CR9FBS
Health Canada · #APR-L1K2Y7TW · 2018-07-01
Drug Approval Y2ZF80
Health Canada · #APR-ZWJC478P · 2021-09-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-A2TIBT2P
Issued: 2020-02-12
Expires: 2025-11-02
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-I55MA107
Issued: 2020-03-21
Expires: 2025-10-20
Health Canada GMP
Health Canada
Cert #: CERT-0APB0I2O
Issued: 2020-08-15
Expires: 2025-08-11
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Key facts about Astrea Pharma
- Astrea Pharma is headquartered in France.
- Astrea Pharma was founded in 1990.
- Astrea Pharma has 1,107 employees.
- Astrea Pharma has one manufacturing site listed on CDMO Hub, in Monts, France.
- Astrea Pharma's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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