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Ban imposed on medicines manufactured by Maryland-based contract manufacturing organization by EMA’s CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended to ban the medicines manufactured by Maryland-based contract manufacturing organization (CMO) Pharmaceutics International (Pii) and that the medicines should no longer be available in the EU, except for Ammonaps (sodium phenyl butyrate), which is used to treat a rare disease and is considered critical for public health.

The ban was imposed on account of good manufacturing practice (GMP) review after a follow-up inspection of the site by the UK’s Medicines and Health products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA).

The inspectors observed a "failure of organizational and technical measures to minimize the risk of cross-contamination between hazardous and non-hazardous products manufactured in the same manufacturing facilities using shared equipment as well as found failure of the quality unit to ensure the effective operation of the quality system," at both sites during inspections that ended in February. According to the inspectors the sites displayed a "gross failure of change management," by using an "unqualified" high-performance liquid chromatography system, and an employing an "unacceptable approach to production equipment qualification."The inspectors also found that the corrective measures previously agreed to had not been appropriately implemented.

The medicines which will get impacted due to CHMP recommendations include:

• Ammonaps which is a medicine to treat urea cycle disorders will remain available where alternative treatment options are not there and 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 Pii 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.
• Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone) and associated names are registered to be produced at Pii, but are now manufactured at alternative registered manufacturing sites. The medicines from these alternative sites will therefore remain available in the EU.

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.



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