Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Ofichem Group is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Netherlands
Founded:2013
Employees:1,791
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
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
Manufacturing Facilities
1 site worldwide
Laboratorium Ofichem BV
Heembadweg 5, Ter Apel, CZ, 9561
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval SKDIA7
EMA · #APR-0X9DXXJE · 2019-02-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-0L65KOPA
Issued: 2020-06-14
Expires: 2025-11-18
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-XU4BD433
Issued: 2020-04-12
Expires: 2025-12-13
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-4UCGR3NS
Issued: 2020-02-19
Expires: 2025-01-28
WHO GMP
World Health Organization
Cert #: CERT-YQFL3SCS
Issued: 2020-02-19
Expires: 2025-12-25
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Key facts about Ofichem Group
- Ofichem Group is headquartered in the Netherlands.
- Ofichem Group was founded in 2013.
- Ofichem Group has 1,791 employees.
- Ofichem Group has one manufacturing site listed on CDMO Hub, in Ter Apel, Netherlands.
- Ofichem Group's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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