Janssen-Cilag switches Haldol supplies to Switzerland after production problems

By Gareth Macdonald contact

- Last updated on GMT

Janssen-Cilag switches Haldol supplies to Switzerland after production problems
Problems at a CMO have forced Janssen-Cilag to ship Haldol made in Austria to patients in Switzerland to maintain supplies.

The Johnson & Johnson division (J&J) announced the temporary change to its supply chain in an ‘out of stock’ notification letter published on the Swissmedic website last night (here​ in French).

It cautioned that while the quality of the Austria-made replacement products is the same, the packages contain twice as many Haldol (haloperidol) ampoules as those usually shipped to Switzerland.

The firm cited an unspecified “production and supply problem with the Swiss preparation Haldol solution for injection​” and said supply change had been agreed with Swissmedic.

CMO problems

A spokeswoman said: “Janssen is facing potential shortages due to a temporary, and voluntary, interruption of production at a third-party manufacturing site earlier in 2016."

She added the firm is working with manufacturing partners and regional health authorities to resolve supply shortages of these products as quickly and effectively as possible to minimize patient impact.​” 

Production has restarted at the facility in question "but it will take some time to return to full manufacturing capacity​” she continued.

Haldol is an antipsychotic indicated for the treatment of a range of psychological conditions, from schizophrenia and Tourette syndrome to mania in bipolar disorder and hallucinations in alcohol withdrawal. 

Stock out

A Swissmedic spokesman explained that Janssen’s request to supply from Austria is covered under Switzerland’s ‘stock-out’ procedures.

If a therapeutically important authorized medicinal product is not available in Switzerland for a limited period due to a stock-out situation, the holder of the license can request for approval of a temporary distribution of an identical preparation in a foreign packaging." 

Related topics: Markets & Regulations, Regulations

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