Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Purisys is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:United States
Founded:1996
Employees:962
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
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Purisys LLC
1550 Olympic Drive, Athens, Georgia, 30601
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval 4AUM98
FDA · #APR-GIOKQ21V · 2020-03-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-SWGEY4EV
Issued: 2020-04-18
Expires: 2025-07-13
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-GYCWFOSS
Issued: 2020-03-04
Expires: 2025-06-25
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-E9K6HXJ5
Issued: 2020-03-04
Expires: 2025-01-23
Health Canada GMP
Health Canada
Cert #: CERT-YZYBLKZP
Issued: 2020-01-23
Expires: 2025-08-12
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Key facts about Purisys
- Purisys is headquartered in the United States.
- Purisys was founded in 1996.
- Purisys has 962 employees.
- Purisys has one manufacturing site listed on CDMO Hub, in Athens, United States.
- Purisys's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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