Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Alpex Pharma SA is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Switzerland
Founded:1997
Employees:172
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
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
North America
Europe
Manufacturing Facilities
1 site worldwide
Alpex Pharma SA
Via Cantonale, Mezzovico, 6805
Site Capabilities
1 capabilityMANUFACTURE
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval PT8NXQ
FDA · #APR-MFN3S98A · 2021-07-01
Drug Approval MK7ZMC
EMA · #APR-OY01P2W2 · 2019-12-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-7K07MXQT
Issued: 2020-11-23
Expires: 2025-07-06
WHO GMP
World Health Organization
Cert #: CERT-UD25GU0Q
Issued: 2020-01-25
Expires: 2025-09-22
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Key facts about Alpex Pharma SA
- Alpex Pharma SA is headquartered in Switzerland.
- Alpex Pharma SA was founded in 1997.
- Alpex Pharma SA has 172 employees.
- Alpex Pharma SA has one manufacturing site listed on CDMO Hub, in Mezzovico, Switzerland.
- Alpex Pharma SA's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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