The European Medicines Agency (EMA) review is focussing on Ammonaps (sodium phenylbutyrate), the centrally authorised medicine urea cycle disease treatment Pii makes at the Hunt Valley site.
The Agency said it is also reviewing several other Pii drugs that have been authorised through national procedures in the European Union (EU), but did not provide details.
The EMA said its “Committee for Medicinal Products for Human Use (CHMP) will now review the impact of the inspection findings on the products’ overall benefits and risks and make a recommendation as to whether any changes are needed to their marketing authorisations.”
The EMA added that while there is no evidence patients have been put at risk, neither Pii site will be allowed to supply drugs to the EU as a precautionary measure unless they are deemed to be critical by national regulators.
Pii medicines that are not considered to be critical by National authorities will be recalled.