Production at Teva API plant halted until next year

Teva production
Teva has told customers of its active pharmaceutical ingredient plant in Italy that production has been halted until next year. (Teva)

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. 

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

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." 

RELATED: Teva CEO says manufacturing cuts will keep coming even after $3B reduction achieved

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. 

Suggested Articles

At one point, Novartis even offered up $90 apiece for the inclisiran developer but would later say even $85 was too much, a securities filing shows.

Sanofi spent months hyping its Tuesday investor event, and new CEO Paul Hudson certainly laid out a different vision for the drugmaker at the confab.

After more than 10 years as partners, Sanofi and Regeneron are splitting up their deal to comarket PCSK9 med Praluent and immunology drug Kevzara.