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Dutch hospital’s manufacture of drug for rare condition was legal, says inspectorate

BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5127 (Published 03 December 2018) Cite this as: BMJ 2018;363:k5127
  1. Tony Sheldon
  1. Utrecht, Netherlands

A five month investigation by Dutch health inspectors into a leading university hospital’s cost price production of orphan drug chenodeoxycholic acid (CDCA) has concluded that such “small scale” preparation is legal.

But, it has halted the Amsterdam University Medical Center’s current production of the primary bile acid used to treat the rare hereditary metabolic disorder cerebrotendinous xanthomatosis on safety grounds. Tests carried out on behalf of the Dutch Healthcare Inspectorate showed that the raw materials used in the drug’s production had potentially dangerous levels of unknown impurities.

The hospital has welcomed the principle that their action is legal, although Leadiant Biosciences, which has a 10 year market exclusivity on the drug from …

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