J‑STAR Research, Inc.
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
J‑STAR Research, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United States
Founded:1991
Employees:663
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Manufacturing Facilities
2 sites worldwide
J-Star Research Inc.
3001 Hadley Road, Suites 1-5A, South Plainfield, New Jersey, 07080
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
J-Star Research Inc
6 Cedarbrook Dr., Cranbury, New Jersey, 08512
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
Regulatory Approvals
Drug Approval HNX04S
EMA · #APR-NFS5IRSV · 2020-06-01
Drug Approval XH6TN0
FDA · #APR-0YLX5MLQ · 2022-10-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-CC357S2O
Issued: 2020-12-12
Expires: 2025-01-10
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-NPWNHPWT
Issued: 2020-07-13
Expires: 2025-09-18
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-CRAYAGIP
Issued: 2020-04-23
Expires: 2025-12-18
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-T634PZGI
Issued: 2020-05-25
Expires: 2025-09-17
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Key facts about J‑STAR Research, Inc.
- J‑STAR Research, Inc. is headquartered in the United States.
- J‑STAR Research, Inc. was founded in 1991.
- J‑STAR Research, Inc. has 663 employees.
- J‑STAR Research, Inc. has 2 manufacturing sites listed on CDMO Hub, in South Plainfield, United States and Cranbury, United States.
- J‑STAR Research, Inc.'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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