CORDEN PHARMA LATINA S.p.A.

Core Capabilities

  • >> Manufacturer of non-sterile, oral grade cephalosporin & monobactam drug substances
  • >> Manufacturer of sterile cephalosporin & penicillin drug substances
  • >> cGMP manufacturing of sterile powder dosage forms for cephalosporins
  • >> cGMP manufacturing of oral (tablets and capsules) and injectables (liquid and lyo) cytotoxic/cytostatic products
  • >> Full range of development & packaging services
  • >> Serialization program in place as per current market requirements
  • >> Full Pharma supply chain

COMPLIANCE APPROVALS

  • >> EMA (AIFA) - 2019
  • >> FDA - 2019
  • >> Russian MoH - 2017
  • >> Turkish MoH - 2017
  • >> ANVISA - 2017
  • >> Korean MoH - 2016
  • >> Japanese MoH – 2015

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.

Scope of EHS Management System

CordenPharma Latina SHE Policy (English)

CordenPharma Latina SHE Policy (Italian)

CordenPharma Latina UNI EN ISO 14001:2015 Certification

CordenPharma Latina UNI ISO 45001:2018 Certification

Facility Legacy

Corden Pharma Latina S.p.A. is a fully integrated manufacturer of oral and sterile anti-infective penicillins & cephalosporins for the supply of both API & Drug Products to the worldwide marketplace. The site also has extensive experience and focus on oral and sterile oncological formulation. 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
  • >> 2018 - Acquired by a Third Party (not affiliated to CordenPharma)
  • >> 2021 - Annex 1 upgrade: API Ceph Sterile & Onco Sterile 2nd line

Managing Director

Filippo Rolando

Corden Pharma Latina S.p.A.*

Via Murillo, 7
04013 Sermoneta
Italy

*Corden Pharma Latina S.p.A. was acquired by a Third Party (not affiliated to CordenPharma)

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

Email Human Resources