Manufacturing & Lab Equipment
Regulatory, Tech Transfer & Support Services
Company Overview
About
Simac Masic bv is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Netherlands
Founded:2004
Employees:495
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
Regulatory Approvals
Drug Approval GGSKYN
Health Canada · #APR-0YIWKZ15 · 2019-03-01
Drug Approval 1XCBWK
FDA · #APR-B1E6K56Y · 2018-11-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-O3KCWCC4
Issued: 2020-02-09
Expires: 2025-01-02
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-4CT6R5I6
Issued: 2020-04-26
Expires: 2025-06-06
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-4EBR0LU4
Issued: 2020-02-21
Expires: 2025-12-18
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Key facts about Simac Masic bv
- Simac Masic bv is headquartered in the Netherlands.
- Simac Masic bv was founded in 2004.
- Simac Masic bv has 495 employees.
- Simac Masic bv's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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