Drug Product
Excipients & Specialty Ingredients
Regulatory, Tech Transfer & Support Services
Company Overview
About
Nagase & Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Neurology
Quick Facts
HQ:Japan
Founded:2002
Employees:467
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval 4QH8F2
PMDA · #APR-DXXSA29C · 2021-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-M7TK7WQ3
Issued: 2020-12-26
Expires: 2025-11-22
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-R7X6P3ZC
Issued: 2020-12-03
Expires: 2025-07-27
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-8L3UWZAM
Issued: 2020-03-27
Expires: 2025-05-24
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-LNHRX9MO
Issued: 2020-01-01
Expires: 2025-09-26
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Key facts about Nagase & Co., Ltd.
- Nagase & Co., Ltd. is headquartered in Japan.
- Nagase & Co., Ltd. was founded in 2002.
- Nagase & Co., Ltd. has 467 employees.
- Nagase & Co., Ltd.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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