Manufacturing & Lab Equipment
Regulatory, Tech Transfer & Support Services
Company Overview
About
Topa Thermal 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:Netherlands
Founded:2016
Employees:520
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
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Global
Regulatory Approvals
Drug Approval 9DVVAI
PMDA · #APR-6B53KZ4Q · 2018-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-GDTL0VY8
Issued: 2020-08-02
Expires: 2025-04-23
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-2K7E7ID0
Issued: 2020-04-22
Expires: 2025-12-11
WHO GMP
World Health Organization
Cert #: CERT-H871PO99
Issued: 2020-07-23
Expires: 2025-02-01
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-199T8HK9
Issued: 2020-05-22
Expires: 2025-12-19
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Key facts about Topa Thermal
- Topa Thermal is headquartered in the Netherlands.
- Topa Thermal was founded in 2016.
- Topa Thermal has 520 employees.
- Topa Thermal's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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