Sanofi has restarted production at a plant where manufacturing had to be halted to fix pollution issues. The interruption created spot shortages of seizure drugs Epilim and Depakote in some markets, but Sanofi has assured patients it has nothing to do with the impending divorce of the U.K. and the European Union.
In a statement this week to Epilepsy Today, the company said that while patients may have to substitute a tablet for a liquid dose, or vice versa, and dosing may be affected, there are supplies of the two drugs are now available in the U.K.
“Due to temporary disruption in the production of valproate at a Sanofi manufacturing site outside of the U.K., stock levels for some treatments of valproate may be lower than usual. Sanofi is managing the situation carefully and working to ensure continued supply of valproate across all markets, including the U.K.,” it told the publication.
“This temporary disruption in supply of some valproate-based treatments is not related to Brexit,” Sanofi said.
Sanofi halted production at the manufacturing plant in Mourenx, France in July after complaints from France Nature Environment that plant emissions, including cancer-causing bromopropane, were polluting the area. The API plant makes valproate, the active ingredient in seizure drugs Epilim and Depakote and bipolar drug Depamide. In an email to FiercePharma Wednesday, the company said production has resumed.
“We took the issue of the Mourenx plant very seriously. The teams have now fully resolved the problem and the plant is continuing normally its activity to provide an essential drug for millions of patients in France and around the world,” the Sanofi spokesman said. “Stock levels for some treatments of valproate may be lower than usual as we speak. But we are working to reduce this issue.”
The supply issues have materialized as the battle over Brexit has left drugmakers taking extraordinary steps to insure supplies in the face of possible border delays. Officials and drugmakers have warned that unless a Brexit deal makes accommodations to guarantee the free flow of medicines, shortages of essential drugs could materialize.