2 Authorisations granted for 4-tert-OPnEO

Europe
Written By Cathrin Cailliau

On 30 September 2022, the European Commission granted 2 Authorisations for the following substance:

  1. 4-(1,1,3,3-Tetra methylbutyl)phenol, ethoxylated (4-tert-OPnEO)

The Authorisations are held by 2 companies and concern 2 Authorised uses:

  1. Authorisation number REACH/22/29/0 is held by Vetter PharmaFertigung GmbH & Co. KG, and approves the use of 4-tert-OPnEO as an emulsifier in the siliconisation of glass containers (syringes and cartridges) used as primary packaging material for medicinal products of several pharmaceutical companies listed in the confidential Appendix 1 to the analysis of alternatives included in the application.

  2. Authorisation number REACH/22/30/0 is held by LETI Pharma, S.L.U., and approves the use of 4-tert-OPnEO in aqueous buffers during the manufacturing process of the active pharmaceutical ingredient (Protein Q) of the veterinary vaccine LetiFend®.

Cathrin Cailliau
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