Heinlein Plastik-Technik GmbH
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Manufacturing & Lab Equipment
Company Overview
About
Heinlein Plastik-Technik GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Germany
Founded:1996
Employees:189
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval N2EJDS
PMDA · #APR-ROD2DHMN · 2020-01-01
Drug Approval 6ZAYSE
EMA · #APR-BXLZS2K7 · 2021-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-2AAHIUUD
Issued: 2020-09-12
Expires: 2025-09-19
WHO GMP
World Health Organization
Cert #: CERT-O8D410MI
Issued: 2020-10-19
Expires: 2025-11-22
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-X7GBZWWQ
Issued: 2020-11-24
Expires: 2025-07-07
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Key facts about Heinlein Plastik-Technik GmbH
- Heinlein Plastik-Technik GmbH is headquartered in Germany.
- Heinlein Plastik-Technik GmbH was founded in 1996.
- Heinlein Plastik-Technik GmbH has 189 employees.
- Heinlein Plastik-Technik GmbH's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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