Drug Product
Excipients & Specialty Ingredients
Company Overview
About
RemeCure APS is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Denmark
Founded:2010
Employees:857
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
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval PIVSYL
PMDA · #APR-ENAG7JVY · 2021-11-01
Drug Approval 1NTJMM
Health Canada · #APR-BW5A33CR · 2018-08-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-9CKOORM1
Issued: 2020-11-24
Expires: 2025-03-16
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-ZKUSS71R
Issued: 2020-07-05
Expires: 2025-04-03
Health Canada GMP
Health Canada
Cert #: CERT-RD76LIHQ
Issued: 2020-08-19
Expires: 2025-01-14
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Key facts about RemeCure APS
- RemeCure APS is headquartered in Denmark.
- RemeCure APS was founded in 2010.
- RemeCure APS has 857 employees.
- RemeCure APS's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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