Nippon Fine Chemical Co., Ltd.
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Drug Product
Advanced Modalities
Excipients & Specialty Ingredients
Company Overview
About
Nippon Fine Chemical Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Japan
Founded:2000
Employees:2,906
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
North America
Manufacturing Facilities
1 site worldwide
NIPPON FINE CHEMICAL CO.,LTD
5-1-1, UMEI, TAKASAGO, HYOGO, 676-0074
Site Capabilities
2 capabilitiesANALYSIS
MANUFACTURE
Regulatory Approvals
Drug Approval NX6JLB
FDA · #APR-93QI1C93 · 2020-03-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-8QEJFPDP
Issued: 2020-04-12
Expires: 2025-04-08
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-10FQC6NI
Issued: 2020-05-28
Expires: 2025-06-08
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-8LX34QF3
Issued: 2020-12-19
Expires: 2025-05-03
Health Canada GMP
Health Canada
Cert #: CERT-GJZY717T
Issued: 2020-03-18
Expires: 2025-05-11
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Key facts about Nippon Fine Chemical Co., Ltd.
- Nippon Fine Chemical Co., Ltd. is headquartered in Japan.
- Nippon Fine Chemical Co., Ltd. was founded in 2000.
- Nippon Fine Chemical Co., Ltd. has 2,906 employees.
- Nippon Fine Chemical Co., Ltd. has one manufacturing site listed on CDMO Hub, in TAKASAGO, Japan.
- Nippon Fine Chemical Co., Ltd.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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