Stira Pharmaceuticals (Sterile Injectable CDMO)
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Stira Pharmaceuticals (Sterile Injectable CDMO) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:United States
Founded:2008
Employees:1,536
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Global
Manufacturing Facilities
1 site worldwide
STIRA PHARMACEUTICALS LLC
161 Dwight PI, Fairfield, New Jersey, 07004-3026
Site Capabilities
3 capabilitiesANALYSIS
MANUFACTURE
PACK
Regulatory Approvals
Drug Approval PWF44P
PMDA · #APR-6N4PYMJI · 2020-04-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-6Q839BD5
Issued: 2020-11-27
Expires: 2025-02-08
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-3ZV9ZTVQ
Issued: 2020-05-27
Expires: 2025-07-17
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Key facts about Stira Pharmaceuticals (Sterile Injectable CDMO)
- Stira Pharmaceuticals (Sterile Injectable CDMO) is headquartered in the United States.
- Stira Pharmaceuticals (Sterile Injectable CDMO) was founded in 2008.
- Stira Pharmaceuticals (Sterile Injectable CDMO) has 1,536 employees.
- Stira Pharmaceuticals (Sterile Injectable CDMO) has one manufacturing site listed on CDMO Hub, in Fairfield, United States.
- Stira Pharmaceuticals (Sterile Injectable CDMO)'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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