Manufacturing & Lab Equipment
Regulatory, Tech Transfer & Support Services
Company Overview
About
tempmate GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Germany
Founded:1993
Employees:329
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
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Regulatory Approvals
Drug Approval J8SCVJ
EMA · #APR-XC6EDM5N · 2022-09-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-ZCIXKF50
Issued: 2020-09-03
Expires: 2025-06-13
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-NAFA7CSP
Issued: 2020-02-22
Expires: 2025-03-25
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-FWIA1TY2
Issued: 2020-05-23
Expires: 2025-03-25
WHO GMP
World Health Organization
Cert #: CERT-MRE85A1X
Issued: 2020-12-21
Expires: 2025-01-04
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Key facts about tempmate GmbH
- tempmate GmbH is headquartered in Germany.
- tempmate GmbH was founded in 1993.
- tempmate GmbH has 329 employees.
- tempmate GmbH's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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