EMA cites Slovakian sterile drugmaker and says its meds should be recalled
The European Medicines Agency has taken action against a Slovakian sterile drugmaker after inspectors tallied up nearly two dozen issues.
An inspection last month of the Unimed Pharma plant in the Slovakian capital of Bratislava found two critical deficiencies and 21 major shortcomings, most around pharma quality, according to a report posted by the European Medicines Agency.
The inspectors found that Unimed fell short in most of the basic GMP areas finding that in addition to issues with potential cross-contamination and quality assurance, the drugmaker was not even capable of designing, planning and implementing procedures “to ensure the consistent delivery of products with appropriate quality attributes, whilst the ‘Major’ deficiencies were cited for inadequate documentation management, validation activities and lack of trained personnel.”
The Slovakian authorities withdrew the manufacturing certificate for Unimed and recommended that countries that are using the company's meds recall them unless there are no alternatives for specific products. In that case, it said local authorities should make sure that Unimed’s sterile injectable meds are retested to make sure they will be safe and effective.
Slovakia has not drawn much interest from Western drugmakers. In 2012 Sanofi’s Zentiva bailed out of the country and sold its API and drug manufacturing facility in Hlohovec, Slovakia, to Wood Pharma Holding. In 2014, India’s Cipla struck a deal with S&D Pharma to distribute its generic drugs in the Czech Republic and Slovakia.
While the Slovakian drug industry is not known widely, Slovakia-based CDMO Saneca Pharmaceuticals is a noted maker of opiate APIs. The Hlohovec-based company operates from a site that has been making APIs for 75 years.
Jan 23, 2019https://www.fiercepharma.com/