A little flexibility in approach will improve consistency and enable pharma partners to perform to their optimum level. Ahead of her presentation on ‘How to Build a ‘Framework for Managing Your Outsourcing Partner’ at CPhI North America, we spoke with Stephanie Gaulding, executive director of regulatory compliance at Pharmatech Associates
CDMO EuroAPI has been listed on the Euronext Paris market as of 5 May. CEO Karl Rotthier said that the listing “marks an exciting milestone for the development of our company as it will enable us to consolidate our leadership in the dynamic API market”.
Private equity firm Atorg has agreed to acquire CDMO CordenPharma from International Chemical Investors Group (ICIG), subject to customary regulatory approvals. The founders, Patrick Schnitzer and Dr Achim Riemann, will also reinvest in the firm and CEO Michael Quirmbach remains in place.
CDMO Onyx Scientific has opened a second facility at its headquarters site in Sunderland, UK.This doubles its footprint and allows for expansion of all CMC activities, including additional GMP facilities that increases capacity for GMP and commercial API manufacturing capacity by 50%.
Dow has announced plans to expand its alkoxylation capacity in the US and Europe in 2024 and 2025. The investments are backed by supply agreements with customers and are being made to meet 10-15%/year growth in end markets including home and personal care, industrial and institutional cleaning, pharmaceuticals and crop protection.
Bachem has entered a strategic collaboration under which it will provide the infrastructure and expertise to implement Eli Lilly & Company’s novel manufacturing technology for oligonucleotide APIs. It will also supply R&D and production at its site in Bubendorf, Switzerland, to make GMP-grade material using this technology.
Sumitomo Chemical has announced plans to build a new plant for APIs and intermediates to come onstream in September 2024 at its Oita works on the southern tip of Honshu. This comes in response to growing demand from the small molecule sector. No financial details were given.
Oita, the company said, “can manufacture a wide variety of APIs and intermediates that require complex chemical reactions and also flexibly scale from development to commercialisation”. It is also compliant with EU, US and Japanese GMP standards.
