MoNo chem-pharm Produkte GmbH
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Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
MoNo chem-pharm Produkte GmbH is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Austria
Founded:2008
Employees:937
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Europe
International Regulatory
EU GMP Certificates
21
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval S6L2JG
FDA · #APR-G982KS3F · 2018-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-QKE689CJ
Issued: 2020-02-06
Expires: 2025-09-19
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-YJJCRAHK
Issued: 2020-01-24
Expires: 2025-03-06
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Key facts about MoNo chem-pharm Produkte GmbH
- MoNo chem-pharm Produkte GmbH is headquartered in Austria.
- MoNo chem-pharm Produkte GmbH was founded in 2008.
- MoNo chem-pharm Produkte GmbH has 937 employees.
- MoNo chem-pharm Produkte GmbH's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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