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

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

Managing Director

Fabrizio Fiordigiglio

Corden Pharma S.p.A.

Viale dell’Industria, 3
20867 Caponago
Monza Brianza
Italy

Phone: +39 02 95452 1
Fax: +39 02 95452 300

Email Human Resources