5N Plus
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Excipients & Specialty Ingredients
Company Overview
About
5N Plus is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Canada
Founded:2005
Employees:2,514
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
North America
Manufacturing Facilities
1 site worldwide
5N Plus Lübeck GmbH
Kaninchenborn 28, Lübeck, Schleswig-Holstein, 23560
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval 59T6HC
Health Canada · #APR-SS1XGLBZ · 2021-04-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-9LFNM661
Issued: 2020-08-10
Expires: 2025-03-02
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-FBCE9CYN
Issued: 2020-01-02
Expires: 2025-10-17
WHO GMP
World Health Organization
Cert #: CERT-9X1VWVAK
Issued: 2020-11-15
Expires: 2025-09-16
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-BJYQCOBS
Issued: 2020-12-10
Expires: 2025-03-01
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Key facts about 5N Plus
- 5N Plus is headquartered in Canada.
- 5N Plus was founded in 2005.
- 5N Plus has 2,514 employees.
- 5N Plus has one manufacturing site listed on CDMO Hub, in Lübeck, Germany.
- 5N Plus's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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