Drug Product
Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
PeptiStar Inc. 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:1999
Employees:2,816
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 XEFNNK
PMDA · #APR-6JXHY2MW · 2019-02-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-4I5GYLGY
Issued: 2020-10-13
Expires: 2025-12-14
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-90IUPO5S
Issued: 2020-05-04
Expires: 2025-03-17
Health Canada GMP
Health Canada
Cert #: CERT-1TQF34LZ
Issued: 2020-04-01
Expires: 2025-08-23
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-TH6N2DQJ
Issued: 2020-02-16
Expires: 2025-03-08
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Key facts about PeptiStar Inc.
- PeptiStar Inc. is headquartered in Japan.
- PeptiStar Inc. was founded in 1999.
- PeptiStar Inc. has 2,816 employees.
- PeptiStar Inc.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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