Ammonaps may still be supplied where no alternatives are available

The European Medicines Agency (EMA) has recommended that medicines manufactured by Pharmaceutics International Inc., located in the United States, should no longer be available in the EU, except Ammonaps (sodium phenylbutyrate), which is considered to be critical for public health.

The recommendation is the outcome of a review into issues with good manufacturing practice at Pharmaceutics International Inc. The review was started after a follow-up inspection of the site by the UK medicines regulatory agency (MHRA) and the US FDA. This inspection found that corrective measures previously agreed had not been appropriately implemented. In particular, several manufacturing shortcomings had not been resolved. These related to the risk of cross-contamination (the possible transfer of one medicine to another) and deficiencies in the systems for ensuring medicines’ quality (quality assurance).

Although there is no evidence of a defect in any of the medicines produced at the site or of harm to patients, EMA’s Committee for Medicinal Products for Human Use(CHMP) concluded, as a precaution, that supply of non-critical medicines should be stopped. In addition, CHMP requested the site to implement corrective measures to ensure compliance with GMP standards.

The Committee’s recommendation will have the following impact on availability of medicines from Pharmaceutics International Inc.:

  • Ammonaps, a medicine for treating urea cycle disorders which is exclusively manufactured at Pharmaceutics International Inc., will remain available where there are no treatment alternatives. In EU countries where treatment alternatives exist Ammonaps will be recalled.
  • SoliCol D3 (cholecalciferol), a medicine for vitamin D deficiency which is also exclusively produced at Pharmaceutics International Inc. but has not yet been marketed in the EU, will not be made available in the EU. The medicine can only be marketed once evidence is provided that its manufacturing is compliant with GMP standards.
  • The medicines Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone), and associated names, are registered to be produced at Pharmaceutics International Inc., but are now manufactured at alternative registered manufacturing sites. The medicines from these alternative sites will therefore remain available in the EU. For Lutigest/Lutinus, some batches produced at the US site are still available on the EU market and will be recalled.

The CHMP’s recommendation concerning these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU.

Posted on the EMA website on 16 September 2016