CORDENPHARMA SWITZERLAND (LIESTAL, CH)

Core Capabilities

Feasibility Studies & Process Development

  • >> Experts for route scouting & process development for exclusive compounds
  • >> Small molecule APIs, key intermediates & chiral building blocks
  • >> Special expertise in lipids, carbohydrates, & conjugates thereof

cGMP Manufacture

  • >> Experts in developing & manufacturing small molecule APIs and other chemically synthesized materials (small, scale-up & commercial scale)
  • >> Active Pharmaceutical Ingredients (APIs)
  • >> Advanced key intermediates

Analytical Support

  • >> Analytical development & validation
  • >> Cleaning method development & validation

Quality & Regulatory Support

  • >> Stability studies
  • >> Preparation of CMC sections
  • >> Filing & maintenance of US-DMFs, ASMFs & others

Project Management

  • >> Strong expertise in project management
  • >> Critical Chain Project Management (CCPM) established
  • >> Project management according to stage gate process
  • >> Interdisciplinary project teams established for each project
  • >> Regular customer interactions as mutually agreed upon

COMPLIANCE

Highly cGMP Focused & Appropriate Certificates

  • >> API manufacturing and analytical testing

Inspected by Authorities

  • >> Swissmedic (Quality System Inspections) > Most Recent 2018
  • >> US FDA (Pre-approval and Quality System Inspections) > Most Recent 2014
  • >> Russian Health Authority > Most Recent 2017

Facility Legacy

CordenPharma Switzerland is a cGMP manufacturing facility with expertise in the production of high quality chemical intermediates and active pharmaceutical ingredients including lipids, small molecules, GalNac and carbohydrates.

Formerly a business unit of Genzyme Corporation, CordenPharma Switzerland brings extensive API manufacturing capability while adding strength to an existing lipid development and manufacturing business within CordenPharma’s full-service CDMO platform.

HISTORY

  • >> 1994: Genzyme Pharmaceuticals acquired Sygena AG, a Swiss facility focused on the production of high quality chemical intermediates & APIs
  • >> 1999: Sygena officially changed its name to Genzyme Pharmaceuticals
  • >> 2011: Genzyme Pharmaceuticals acquired by ICIG to become Corden Pharma Switzerland LLC
 

Managing Director

Juerg Burger

Corden Pharma Switzerland LLC

Eichenweg 1
4410 Liestal
Switzerland

[email protected]

Phone: +41 61 906 59 59
Fax: +41 61 906 59 58

Email Human Resources