O.F.I. Officina Farmaceutica Italiana
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Drug Product
Company Overview
About
O.F.I. Officina Farmaceutica Italiana is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Italy
Founded:2014
Employees:845
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
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
OFI Technologie & Innovation GmbH
Franz-Grill-Strasse 5, Objekt 213, Vienna, 1030
Site Capabilities
1 capabilityANALYSIS
Regulatory Approvals
Drug Approval CRNC2L
EMA · #APR-XZMWL2QR · 2020-09-01
Drug Approval PY7M4V
Health Canada · #APR-KHKMPMVD · 2021-03-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-20ET50YZ
Issued: 2020-06-05
Expires: 2025-02-19
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-XMD0H04M
Issued: 2020-09-07
Expires: 2025-08-11
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Key facts about O.F.I. Officina Farmaceutica Italiana
- O.F.I. Officina Farmaceutica Italiana is headquartered in Italy.
- O.F.I. Officina Farmaceutica Italiana was founded in 2014.
- O.F.I. Officina Farmaceutica Italiana has 845 employees.
- O.F.I. Officina Farmaceutica Italiana has one manufacturing site listed on CDMO Hub, in Vienna, Austria.
- O.F.I. Officina Farmaceutica Italiana's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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