Stella Kunststofftechnik GmbH
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Manufacturing & Lab Equipment
Company Overview
About
Stella Kunststofftechnik GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Neurology
Quick Facts
HQ:Germany
Founded:1992
Employees:2,174
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Global
Regulatory Approvals
Drug Approval Y9U251
Health Canada · #APR-7FQVSFMV · 2020-02-01
Drug Approval JBXRU3
PMDA · #APR-9Z4VFKN6 · 2021-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-VX94MU1Q
Issued: 2020-02-10
Expires: 2025-03-21
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-J9A53YEJ
Issued: 2020-04-01
Expires: 2025-09-04
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-VIL10O09
Issued: 2020-07-21
Expires: 2025-09-10
WHO GMP
World Health Organization
Cert #: CERT-5DQYSU5C
Issued: 2020-08-20
Expires: 2025-04-22
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Key facts about Stella Kunststofftechnik GmbH
- Stella Kunststofftechnik GmbH is headquartered in Germany.
- Stella Kunststofftechnik GmbH was founded in 1992.
- Stella Kunststofftechnik GmbH has 2,174 employees.
- Stella Kunststofftechnik GmbH's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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