EMA recommends stopping the Supply of Medicines manufactured at U.S. Company

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

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.

This follows a review caused by the issuance of two Non-Compliance Reports for two sites of the US based company after an inspection conducted by the MHRA (the medicines regulatory agency in the United Kingdom) in February 2016. This inspection highlighted several shortcomings in relation to good manufacturing practice (GMP) - see also EMA reviews Medicines manufactured at U.S. Company.

EMA's Committee for Medicinal Products for Human Use (CHMP) has assessed the impact of the inspection findings on the products' overall benefits and risks and recommends that the supply of non-critical medicines to EU 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 will remain available where there are no treatment alternatives. In EU countries where treatment alternatives exist, Ammonaps will be recalled.
• SoliCol D3 (cholecalciferol) is not yet being marketed in the EU and will not be made available.
• Dutasteride Actavis (dutasteride), Lutigest/Lutinus (progesterone) are manufactured at alternative registered manufacturing sites. The medicines from these alternative sites will remain available in the EU. Lutigest/Lutinus batches which were produced at the Pharmaceutics International Inc. site will be recalled.

Source: EMA Press Release