Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Syntese is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Denmark
Founded:1997
Employees:779
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
Syntese A/S
Industriholmen 13, Hvidovre, 2650
Site Capabilities
3 capabilitiesANALYSIS
API MANUFACTURE
LABEL
International Regulatory
EU GMP Certificates
5
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval CEO34A
PMDA · #APR-IC04U9IY · 2020-11-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-JEQDAS4C
Issued: 2020-12-18
Expires: 2025-05-23
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-MFNZHAJP
Issued: 2020-02-13
Expires: 2025-03-27
WHO GMP
World Health Organization
Cert #: CERT-VHXDWBG7
Issued: 2020-04-28
Expires: 2025-11-03
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Key facts about Syntese
- Syntese is headquartered in Denmark.
- Syntese was founded in 1997.
- Syntese has 779 employees.
- Syntese has one manufacturing site listed on CDMO Hub, in Hvidovre, Denmark.
- Syntese's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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