Pfizer CenterOne’s Enviero® receives first EU authorization as part of ESTIMA® (progesterone) product approval.
Pfizer CentreOne’s green-chemistry progesterone API, Enviero®, has been approved for use in the EU for the first time in a drug product manufactured by French pharmaceutical company, Effik.
Effik, part of Italfarmaco Group, has gained European Medicines Agency (EMA) approval to use Enviero® in its ESTIMA® treatment*.
The manufacturer switched to the green-chemistry progesterone API to help enhance its sustainability and environmental performance credentials while ensuring reliable supply.
On this development, Andrew Anderson, API business lead at Pfizer CenterOne said:
We are delighted that Enviero® has been approved for use in the EU market and that it will be used by Effik in a product that is important to patients across the region. Moreover, it’s an important first step to adopting a more sustainable and environmentally friendly progesterone supply across Europe and comes at a vital time as companies increase their focus on greener manufacturing initiatives.
Launched in the US in 2018, Enviero® is manufactured via a proprietary biocatalytic process based on plant sterols that reduces waste, greenhouse gas emissions and hazardous solvents use.
Learn more about Pfizer CenterOne’s Enviero® progesterone API here.
*not approved in the United States.