API Co., Ltd. (Japan)
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Drug Product
Company Overview
About
API Co., Ltd. (Japan) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Japan
Founded:1991
Employees:1,348
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
BSL-2 (Biosafety Level 2)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval 1D2NBQ
EMA · #APR-5GVPU8QG · 2021-05-01
Drug Approval 3VOZAR
PMDA · #APR-K4SOAVT5 · 2022-11-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-9P9RAT0I
Issued: 2020-01-26
Expires: 2025-08-06
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-W2E81JW7
Issued: 2020-08-27
Expires: 2025-01-24
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-1O72VRPV
Issued: 2020-02-22
Expires: 2025-02-14
WHO GMP
World Health Organization
Cert #: CERT-97Z5VWJR
Issued: 2020-12-09
Expires: 2025-09-24
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Key facts about API Co., Ltd. (Japan)
- API Co., Ltd. (Japan) is headquartered in Japan.
- API Co., Ltd. (Japan) was founded in 1991.
- API Co., Ltd. (Japan) has 1,348 employees.
- API Co., Ltd. (Japan)'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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