Health Canada asks importers to quarantine Polydrug APIs over data concerns
Health Canada issued the request last week, describing the move as a precaution to mitigate any risk posed by the ingredients in light of concerns about the integrity of testing data generated by labs at the site.
The regulator stressed that no products containing Polydrug active pharmaceutical ingredients (APIs) had been recalled. It also advised patients not to stop taking medications without consulting a physician.
Polydrug did not respond to a request for comment ahead of publication.
Slovenia
The quarantine request comes days after Slovenian regulator, Jazmp, documented Polydrug’s failure to log customer complaints about its ingredients in a filing on the European Union’s Eudra GMP database.
Jazmp inspectors observed 17 breaches of current good manufacturing practices (GMP) at the facility, five of which it described as ‘major’ including that customer complaints were “deliberately unregistered in the official logbook.”
Other transgressions included that access to quality records is not controlled and that Polydrug failed to “address risks of cross contamination for APIs sent out to micronisation subcontractor” both of which pose a “potential risk for the patient.”
The Ljubljana-based regulator also asked the European Directorate for the Quality of Medicines & HealthCare (EDQM) to suspended certificates of suitability (CEP) for the seven active pharmaceutical ingredients (APIs) made at the Polydrug site.
The affected APIs include the beta blockers metoprolol tartrate and metoprolol succinate, ferrous fumarate and the Pfizer-developed antifungal fluconazole, which is on the World Health Organisation’s (WHO) essential medicines list.
