TopChem Pharmaceuticals
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Drug Product
Excipients & Specialty Ingredients
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
TopChem Pharmaceuticals is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Ireland
Founded:2019
Employees:1,838
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
TOPCHEM PHARMACEUTICALS LIMITED
Ballymote Business Park, Ballymote, F, 56 RX08
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval GDK5YS
EMA · #APR-Q6PPWF88 · 2018-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-15E3VVD6
Issued: 2020-12-13
Expires: 2025-09-26
Health Canada GMP
Health Canada
Cert #: CERT-1IMDNOMV
Issued: 2020-09-06
Expires: 2025-05-03
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Key facts about TopChem Pharmaceuticals
- TopChem Pharmaceuticals is headquartered in Ireland.
- TopChem Pharmaceuticals was founded in 2019.
- TopChem Pharmaceuticals has 1,838 employees.
- TopChem Pharmaceuticals has one manufacturing site listed on CDMO Hub, in Ballymote, Ireland.
- TopChem Pharmaceuticals's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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