will focus on a limited number of substances , mainly for hospitals .
Derisking the chain
The pharmaceutical industry needs to create value chains with long-term resilience . This requires holistic approaches to managing API supply lines and protecting against future disruptions .
Experts and consultancy firms such as Bain & Company or EY provide good insights and paths forward through a typical process of thorough risk assessment and control strategies , resulting in the implementation of capacity buffers , dual sourcing across regions , flexible partnerships and predictive IT tools for better visibility . 5 , 6
However , these proposed measures to derisk the drug substance supply chain , while pertinent and full of common sense , are often quite general and do not capture the root causes of a disruption at the manufacturer level . When going in beyond the accidental disruptions or geopolitical risks , it is important to understand the core strength of a company in producing an API .
In other words , we recommend emphasising the value chain perspective . The question to ask is ‘ In assessing my strategic API supply , is my supplier truly robust in making this molecule for me ?’
Supply chain resilience by design
EuroAPI , a major player in drug substance production created in 2022 from former Sanofi API operations , is rapidly developing its custom services activities for NCEs alongside being one of the largest global producers of commercial small molecule and ‘ tide ’ APIs . After two years of strategic review and adaptation , the company has solid financing for a growth strategy where customers will benefit from a unique level of supply chain integration .
Since EuroAPI achieved its independence , a large-scale real-life exercise has been conducted over 200 commercially produced APIs across its three main technology platforms of small molecule synthesis , microbial fermentation and ‘ tides ’, in order to assess its intrinsic strengths . This exercise is now over .
The review has resulted in a streamlined value-added portfolio focused on highly differentiated APIs . About 10 % of the portfolio molecules were discarded .
Poppy cultivation is the starting point for the Opiates & Derivatives product lines
The survivors are characterised by fundamental strengths to enable long-term , globally competitive positions : a competitive route of synthesis deserving appropriate R & D investment but also a very high level of vertical integration .
The vast majority of EuroAPI ’ s molecule value chains are , by design , deeply integrated . This feature , which might have seemed corporate weakness before COVID , when the disadvantages of increasingly fragmented supply chains were not yet evident , is now a solid base for long-term robustness and is starting to bear fruit .
All of the key products in our small molecules business show a high degree of integration , either through a key RSM associated with an innovative process , such as fexofenadine , produced at the Frankfurt site , or by the belonging to a structured ‘ product tree ’.
Key product trees
For example , EuroAPI is the world ’ s largest producer of prostaglandins with 16 commercial molecules , such as bimatoprost ( for glaucoma ) or treprostinil ( pulmonary arterial hypertension ), which require on average around 15 chemical steps . The main production site in Budapest is supported by a back-up facility in France synthesising early intermediates for contingency and capacity purposes .
It is a similar story in the Corticosteroids & Hormones product line , where the APIs require 15-25 chemical steps on average . These are made at Vertolaye , France – unusually , because advanced intermediates are mostly sourced from China . This integration was critical during the COVID crisis since Vertolaye was producing dexamethasone , among the first COVID medicines to be successfully used .
Integration is even more striking for the Opiates & Derivatives product lines . It starts with some 1,000 farmers making the crude alkaloids precursors , which are
22 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981