EMA quarantines drugs of sterile drugmaker in Spain

European Medicines Agency inspectors found 15 critical deficiencies at a Genfarma plant in Spain. (Genfarma Laboratorio)(Genpharma Laboratorio)

Altan Pharma bought a Spain-based sterile drugmaker three years ago as the base for its plan to become a global specialty pharma player. Now there is a crack in that foundation.

Regulators in Spain have pulled the manufacturing certificate of the Genfarma Laboratorio plant in Toledo after finding big production issues that they said could put patients at risk. Genfarma is one of three operating companies of GES Group, which Altan acquired in 2015.

According to an European Medicines Agency report posted Friday, inspectors said the situation is so severe that they recommended “interim supervisory measures are taken to remove a potential risk to public health.” GES primarily produces drugs for hospitals. While it doesn't ship to the U.S., it sells in Europe, Asia and Latin American countries.

Altan CEO Guillermo Herrera in an email declined to comment. 

RELATED: Spanish sterile injectable player gets snapped up

Investigators reported 38 violations, including 15 critical and 19 major deficiencies in manufacturing processes, quality control activities and sterility assurance. Regulators have quarantined products at the plant and recalled a 50-vial batch of the proton-pump inhibitor pantoprazole, which was confirmed to be out of spec. The report said it had not been released outside of Spain.

In addition to Genfarma Laboratorio, the Madrid-based GES Group includes GES Genéricos Españoles Laboratorio and Biomendi and has been around for more than 30 years. When Altan acquired the company in 2015, it said it had a plant in Madrid and two others in Spain making drip bags.

Terms of the deal were not disclosed at the time, but Altan said it had received a €34.5 million ($38.7 million) investment for the deal from Ireland-based life science equity investor Malin. The company also used additional equity and debt financing to complete the acquisition.