Fresenius Kabi iPSUM S.r.l.
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Fresenius Kabi iPSUM S.r.l. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Italy
Founded:2017
Employees:130
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Production Scales
Pilot Scale
Phase I Clinical Trials
Clinical
Markets Served
North America
Europe
Manufacturing Facilities
3 sites worldwide
Fresenius Kabi USA, LLC
2045 N. Cornell Avenue, Melrose Park, Illinois, 60160
Site Capabilities
1 capabilityANALYSIS
Fresenius Kabi iPSUM S.r.l.
Via San Leonardo 23, Villadose, RO, 45010
Site Capabilities
6 capabilitiesANALYSIS
API MANUFACTURE
LABEL
MANUFACTURE
PACK
STERILIZE
Fresenius Kabi iPSUM S.r.l..
Via Enrico Mattei 26, Vicchio (La Madonna ), /, 50039
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
International Regulatory
EU GMP Certificates
33
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval AMGA2A
Health Canada · #APR-2UIJZXS5 · 2021-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-YG9BHI6K
Issued: 2020-01-22
Expires: 2025-11-12
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-00SBXKUX
Issued: 2020-09-15
Expires: 2025-10-16
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-3AXQZ24W
Issued: 2020-10-28
Expires: 2025-12-12
WHO GMP
World Health Organization
Cert #: CERT-RJ30YIMC
Issued: 2020-11-08
Expires: 2025-02-04
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Key facts about Fresenius Kabi iPSUM S.r.l.
- Fresenius Kabi iPSUM S.r.l. is headquartered in Italy.
- Fresenius Kabi iPSUM S.r.l. was founded in 2017.
- Fresenius Kabi iPSUM S.r.l. has 130 employees.
- Fresenius Kabi iPSUM S.r.l. has 3 manufacturing sites listed on CDMO Hub, in Melrose Park, United States, Villadose, Italy and Vicchio (La Madonna ), Italy.
- Fresenius Kabi iPSUM S.r.l.'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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