Sanofi : The name is ...
Big Pharma giant Sanofi has revealed that the name of its new subsidiary in third party API manufacture , as originally announced in February 2020 , will be EuroAPI . It has also recruited Karl Rotthier from Centrient Pharmaceuticals , formerly DSM Sinochem , to be the CEO . “ Addressing recent increasing medicine shortages that critically impact patient care , EuroAPI will ensure additional API supply capacities for Europe and beyond , and help balancing the industry ’ s heavy reliance on API sourced from other regions ,” Sanofi stated . EuroAPI is a stand-alone company , headquartered in France and employing 3,200 , with a commercial network in more than 80 countries . It combines Sanofi ’ s API commercial and development activities with the six
European production sites at : Brindisi , Italy ; Frankfurt Chemistry , Germany ; Haverhill , UK ; St Aubin les Elbeuf and Vertoloaye , France ; and Újpest in Hungary . From company estimates , based on comparison with data published in annual reports of major API companies , EuroAPI will rank number one in small molecules APIs and number two on the global API market , with some 200 different large-volume and niche APIs . Expected sales are about € 1 billion in 2022 , by when an IPO is planned on Euronext Paris , subject to market conditions . Sanofi intends to retain a minority stake of around 30 %. It “ intends the new company to be debt-free in order to maximise its future investment capacities ”, said Philippe Luscan , EVP of global industrial affairs .
2,900 UK REACH registrations revoked
The European Chemicals Agency ( ECHA ) has revealed that about 2,900 registrations of 268 chemicals by UK-based manufacturers , importers and only representatives under REACH have now been revoked and become void because a transfer from a UK- to a EUbased registrant was not started by the end of the transition period on 31 December 2020 . This equates to about 3 % of all registrations and about 1 % of all registered substances . Of these , about 60 % were registered only for intermediate use , meaning that the market impact of their registration being revoked will be limited . About 80 % of the 2,140 REACH registrant companies in the UK started or completed the transfer process by the end of the year , the agency confirmed . Where these have not yet been completed , EU successors must do so by 31 March or they will no longer be able to legally place the substance on the EU market . In addition , registrations for 237 substances only registered in the UK are currently being transferred from
the UK to the EU . The list has now been updated and is available on the ECHA website . This information will stay there after the revocation . As a result of the transition period ending :
• All pending UK submissions in REACH-IT have been terminated
• No registration numbers will be issued to UK companies
• Companies in the UK cannot perform any actions as duty holders in REACH-IT
• All registrations held by or returned to UK companies will be revoked gradually in REACH-IT The above does not apply to dossiers submitted by companies in Northern Ireland . Due to the Protocol on Ireland and Northern Ireland agreed between the EU and the UK , REACH still covers these companies .
6 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981