Drug Product
Company Overview
About
Pharmalink S.L is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Spain
Founded:2005
Employees:1,676
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
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Europe
Regulatory Approvals
Drug Approval B88Y5T
FDA · #APR-0O7GGW8W · 2021-12-01
Drug Approval 45YU59
FDA · #APR-R5XGUDFX · 2018-02-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-86Y5OYRF
Issued: 2020-11-12
Expires: 2025-02-10
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-660E01MR
Issued: 2020-01-02
Expires: 2025-04-10
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-5D256HNI
Issued: 2020-02-03
Expires: 2025-08-10
Health Canada GMP
Health Canada
Cert #: CERT-82G2RMA5
Issued: 2020-03-10
Expires: 2025-12-07
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Key facts about Pharmalink S.L
- Pharmalink S.L is headquartered in Spain.
- Pharmalink S.L was founded in 2005.
- Pharmalink S.L has 1,676 employees.
- Pharmalink S.L's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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