Teva Pharmaceuticals is having issues with its active pharmaceutical ingredient (API) plant in Italy serious enough that it has had to stop production.
The Israeli drugmaker sent a “Dear Customer” letter to clients saying that it does not expect to restart production until after the first of the year.
“We have been asked by the regulatory authorities to submit new registration requests for products produced at the site. The submission of this documentation will be limited in scope and will not require resubmission of the DMFs (Drug Master Files),” the drugmaker said in an update on the Italian site in Bulciago.
The company said it is working to return to production as quickly as possible but does not expect that will happen "before the end of this year."
A Teva spokesperson did not respond to two requests for comment on what led to the halt in production.
The problems have come up even as the drugmaker has been going through a major downsizing of its manufacturing operations over the last couple of years. That stemmed from CEO Kåre Schultz cutting $3 billion in annual operating expenses to return the drugmaker to firm financial footing after its troubled $40 million deal to buy generic drugmaker Actavis from Allergan. While the drugmaker has very nearly reached its financial goals, Schultz has said that Teva will continue to look at ways to trim the extended manufacturing network.
Cost has not been the only issue with the Actavis buy. Teva received a warning letter earlier this year for a former Actavis site in Florida over issues in the laser drilling of a schizophrenia drug. The FDA noted that the issues predated Teva’s 2016 deal but said the drugmaker hadn’t done enough to get on top of them. Teva, which has brought in an outside consultant, says it is working closely with the FDA.