Monument Chemical bvba
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Drug Product
Excipients & Specialty Ingredients
Company Overview
About
Monument Chemical bvba is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:Belgium
Founded:2009
Employees:2,074
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Asia-Pacific
Regulatory Approvals
Drug Approval W5FGVC
FDA · #APR-FIOXDHGS · 2018-12-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-5IIRNAG6
Issued: 2020-09-24
Expires: 2025-10-21
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-OEJFR3M6
Issued: 2020-07-22
Expires: 2025-01-10
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-N4362VZR
Issued: 2020-08-11
Expires: 2025-01-07
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-6TWC75S9
Issued: 2020-12-26
Expires: 2025-04-18
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Key facts about Monument Chemical bvba
- Monument Chemical bvba is headquartered in Belgium.
- Monument Chemical bvba was founded in 2009.
- Monument Chemical bvba has 2,074 employees.
- Monument Chemical bvba's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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