CORDENPHARMA SWITZERLAND (LIESTAL, CH)
CordenPharma 15 Year Anniversary
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 2021
- >> US FDA (Pre-approval and Quality System Inspections) > Most Recent 2018
- >> Russian Health Authority > Most Recent 2017
Related Products & Platforms
Drug Products
Technology Platforms
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
- >> 2022 Astorg acquires CordenPharma from ICIG
Managing Director
Juerg Burger
Corden Pharma Switzerland LLC
Eichenweg 1
4410 Liestal
Switzerland
Phone: +41 61 906 59 59