Hennig Arzneimittel GmbH & Co. KG
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Hennig Arzneimittel GmbH & Co. KG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Germany
Founded:2009
Employees:1,386
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
OEB 4 (1-10 µg/m³)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Global
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval M6X9IV
PMDA · #APR-EM1HDVRK · 2021-06-01
Drug Approval 326MON
Health Canada · #APR-AIWEZUIP · 2021-12-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-T55QRVF8
Issued: 2020-03-17
Expires: 2025-05-09
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-AC51UWJC
Issued: 2020-12-13
Expires: 2025-09-09
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-NVBPH1Y4
Issued: 2020-12-22
Expires: 2025-04-03
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-V4A3O1T7
Issued: 2020-06-22
Expires: 2025-12-17
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Key facts about Hennig Arzneimittel GmbH & Co. KG
- Hennig Arzneimittel GmbH & Co. KG is headquartered in Germany.
- Hennig Arzneimittel GmbH & Co. KG was founded in 2009.
- Hennig Arzneimittel GmbH & Co. KG has 1,386 employees.
- Hennig Arzneimittel GmbH & Co. KG's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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