Gaelic Laboratories Limited
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Gaelic Laboratories Limited is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Ireland
Founded:2007
Employees:2,030
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval WD2E14
PMDA · #APR-ZZXD6YNT · 2018-04-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-N57VSIER
Issued: 2020-06-25
Expires: 2025-07-09
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-T78PU27B
Issued: 2020-04-07
Expires: 2025-02-05
WHO GMP
World Health Organization
Cert #: CERT-AYKLQK7P
Issued: 2020-11-06
Expires: 2025-10-26
Health Canada GMP
Health Canada
Cert #: CERT-MQ4WB9Z6
Issued: 2020-06-08
Expires: 2025-10-23
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Key facts about Gaelic Laboratories Limited
- Gaelic Laboratories Limited is headquartered in Ireland.
- Gaelic Laboratories Limited was founded in 2007.
- Gaelic Laboratories Limited has 2,030 employees.
- Gaelic Laboratories Limited's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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