Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Alvotech is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Czechia
Founded:2016
Employees:2,805
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 4 (1-10 µg/m³)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Alvotech Hf
Saemundargotu 15-19, Reykjavik, 102
Site Capabilities
5 capabilitiesANALYSIS
API MANUFACTURE
LABEL
MANUFACTURE
PACK
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 2CMZN5
EMA · #APR-RE6KUQL1 · 2019-07-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-R9GFYY81
Issued: 2020-01-12
Expires: 2025-01-03
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-VT350ZXU
Issued: 2020-10-02
Expires: 2025-02-24
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-L9IIEM11
Issued: 2020-11-02
Expires: 2025-09-09
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Key facts about Alvotech
- Alvotech is headquartered in Czechia.
- Alvotech was founded in 2016.
- Alvotech has 2,805 employees.
- Alvotech has one manufacturing site listed on CDMO Hub, in Reykjavik, Iceland.
- Alvotech's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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