Katwijk Chemie BV
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Drug Product
Company Overview
About
Katwijk Chemie BV is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Netherlands
Founded:1992
Employees:2,102
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Manufacturing Facilities
1 site worldwide
B.V. KATWIJK CHEMIE
Snijderstraat 6, Katwijk ZH, 2222
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval H7KAOS
PMDA · #APR-HDO53OUT · 2019-02-01
Drug Approval PI35SP
FDA · #APR-HARTW09A · 2022-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-INVEMNYV
Issued: 2020-01-10
Expires: 2025-05-01
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-YQ4XCODH
Issued: 2020-10-10
Expires: 2025-06-15
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-Z682IA4Q
Issued: 2020-09-28
Expires: 2025-01-02
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Key facts about Katwijk Chemie BV
- Katwijk Chemie BV is headquartered in the Netherlands.
- Katwijk Chemie BV was founded in 1992.
- Katwijk Chemie BV has 2,102 employees.
- Katwijk Chemie BV has one manufacturing site listed on CDMO Hub, in Katwijk ZH, Netherlands.
- Katwijk Chemie BV's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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