U.K. regulators are taking another slice out of Pii, the U.S. CMO that ran afoul of the European Medicines Agency (EMA) earlier this year. The EMA said Monday that it is recommending the ban in Europe of all but one of the drugs manufactured by Pharmaceutics International.
The agency said that while there is “no evidence of a defect in any of the medicines produced at the site or of harm to patients,” the EMA’s Committee for Medicinal Products for Human Use (CHMP) decided to take the steps as a precaution. The lone exception is its sodium phenylbutyrate product, Ammonaps, for treating urea cycle disorders, which the agency said is considered to be critical for public health.
The decision came after a follow-up inspection of Pharmaceutics sites in the U.K. and the U.S. showed that the CMO, based in Hunt Valley, MD, had yet to take steps “previously agreed” upon to remove the risk of cross-contamination and to fix some quality-assurance problems.
The company had said in April that it had hired a team of experts “to address each of the agency’s substantive areas of concern.” It also pointed out that there had been no call by regulators for a recall of any of the products.
The company announced this month that it had received a $93 million investment from a consortium of investors in exchange for an equity stake in the company and debt refinancing and would use some of the money to make “significant capital expenditures in the company’s formulation capabilities and commercial manufacturing operations.”
- here’s the MHRA release
U.K. regulator slaps U.S. CMO Pii for GMP lapses