EMA quarantines drugs of sterile drugmaker in Spain

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


Survey: The Critical Role of Innovation in Launching Successful OTC Products

This research aims to understand the importance of product innovation and dose forms in driving new product design and development, consumer engagement and purchase interest for Over-the-Counter medicines. The first 50 qualified respondents will receive a $5 Amazon gift card. Take the survey now.

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.

Suggested Articles

AveXis' ex-CSO is "prepared to assert his rights and defend his conduct accordingly," a statement from a lawyer who recently represented Elon…

Hikma says it has picked up some pipeline products and nasal and sublingual spray equipment from Insys Therapeutics' bankruptcy.

AstraZeneca is still stinging after its SGLT2 drug Farxiga was waved off in Type 1 diabetes, but new heart failure data could ease the pain.