CORDENPHARMA CAPONAGO (IT)
Sterile Injectable Drug Product Video
CordenPharma 15 Year Anniverary
Core Capabilities
- >> Experts in formulating and packaging parenteral dosage forms
- >> Sterile emulsion technology
- >> Pre-filled syringes
- >> Distribution of clinical trial medication
- >> Formulation development
COMPLIANCE
- >> Inspected by Italian Medicines Agency (AIFA): most recently 2020 (remote)
- >> Inspected by Italian Ministry of Health for veterinary products: most recently 2017
- >> Registered in the EUDRAGMDP database according to EU Directive 62/2011
- >> Relevant GMP Certificates are available on EUDRAGMDP database
- >> The QMS assures compliance to cGMP – as per EU GMP Volume 4 and ICH Q10
- >> According to Italian Decree 219/2006 (EU Directive 2001/83/EC), batch release is performed by Qualified Person
- >> Inspected by US-FDA since 1994 (FEI3002880938): most recently 2020 (remote)
- >> Accredited in Japan since 2009 (AG22000112)
- >> Corden Pharma Caponago Inspections
Corporate Governance
Related Products & Platforms
Related APIs
Technology Platforms
Facility Legacy
CordenPharma Caponago is a cGMP manufacturer of a wide range of sterile liquid dosage forms for injectable use with specialised expertise in terminal sterilization, aseptic fill & finish operations and sterile emulsion technology. The site has full range of capabilities including formulation development, manufacturing, clinical trials management and packaging & pharma-logistics.
As a former AstraZeneca operations site, CordenPharma Caponago brings over 20 years of experience to CordenPharma’s full-service CDMO platform. The site is inspected by EMA (AIFA), FDA, ANVISA, TGA, and the Japanese Authority.
HISTORY
- >> 1970 Foundation
- >> 1987 Expansion to accommodate Diprivan
- >> 1991 Further expansion
- >> 1992 First FDA approval
- >> 2001 Acquired ex–Upjohn Plant
- >> 2005 New plant for Carbapenemic packaging and analysis
- >> 2009 Acquired by ICIG to become Corden Pharma Caponago S.p.A.
- >> 2012 Italian MoH Veterinary approval
- >> 2016 Italian MoH (EU) approval of New Aseptic Dept
- >> 2018 Approval of UP3 aseptic department - line 1 for pre filled syringes production
- >> 2020 Approval of UP3 aseptic department - line 2 for vials production
- >> 2022 Astorg acquires CordenPharma from ICIG
Managing Director
Giuseppe Martelli
Corden Pharma S.p.A.
Viale dell’Industria, 3
20867 Caponago
Monza Brianza
Italy
Phone: +39 02 95452 1
Fax: +39 02 95452 300