CORDENPHARMA LATINA (IT)

Core Capabilities

  • >> cGMP manufacturing of oral & sterile powder dosage forms for cephalosporins, penicillins, liquid and lyo cytotoxics
  • >> Manufacturer of sterile cephalosporin, penicillin & monobactam drug substances
  • >> Full range of development & packaging services
  • >> Serialization program in place as per current market requirements
  • >> Fully integrated infrastructure (solvent recovery, thermal oxidizer, waste water treatment plant)
  • >> Full Pharma supply chain

COMPLIANCE APPROVALS

  • >> EMA (AIFA) - 2017
  • >> ANVISA - 2017
  • >> Korean MoH - 2016
  • >> Japanese MoH - 2015
  • >> FDA - 2013

SAFETY HEALTH & ENVIRONMENT

CordenPharma Latina has a long established tradition of safety, industrial hygiene and environmental awareness. The site culture is built upon strong technical architecture and know-how. The site was certified for environmental systems in 2000 (UNI EN IO 14001) and expanded into the current safety systems in 2002 (BS OHSAS 18001). Since then, a strong commitment and collaboration between management and all employees has led to continuous improvements in the facility and constant renewal of its certifications.

CordenPharma Latina SHE Policy (English)

CordenPharma Latina SHE Policy (Italian)

CordenPharma Latina UNI EN ISO 14001:2004 Certification

CordenPharma Latina BS OHSAS 18001:2007 Certification

Facility Legacy

CordenPharma Latina is a fully integrated manufacturer of oral and sterile anti-infective penicillins and cephalosporins with a special focus on oral and sterile oncological formulation as well as API molecule synthesis. Core capabilities include expertise in process development, process improvement, complex technology transfer as well as new product launches, industrial engineering and scale-up.

Formerly a manufacturing site for Bristol-Myers Squibb, CordenPharma Latina brings over 30 years of experience in manufacturing ß-lactam APIs, oncology products (both parenteral and oral forms) and lyophilized formulations in a full-scale multi-purpose facility.

HISTORY

  • >> 1969 - Foundation
  • >> 1971 - Start of API Penicillin production
  • >> 1975 - Cephalosporin & Penicillin Drug Product Manufacturing begins
  • >> 1983 - Drug Product Oncology Manufacturing Begins
  • >> 1994 - Cephalosporin Drug Product Manufacturing Begins
  • >> 1997 - Start of API Non-Beta Lactam Facility
  • >> 2004 - Start of API Oral Penicillin
  • >> 2005 - Fully Integrated Wastewater Treatment Plant
  • >> 2010 - Acquisition by ICIG to become Corden Pharma Latina S.p.A.
  • >> 2011 - New Drug Product Penicillin Sterile Line
  • >> 2014 - New Drug Product Onco Lyophilisation
  • >> 2014 - New Onco Serialization Line
  • >> 2015 - New Trigeneration
  • >> 2015 - New Onco Liquid & Lyo Facility
  • >> 2016 - Upgrade of Monobactam Facility
 

Managing Director

Eng. Alessandro Zucconi

Corden Pharma Latina S.p.A.

Via del Murillo km2,800
04013 Sermoneta
Italy

Phone: +39 07 73 31 01
Fax: +39 07 73 31 98 55

Email Human Resources