Recipharm reverses decision to close plant in Sweden but faces action on another facility in U.K.

EMA
The EMA has taken action against a Recipharm plant in the U.K. (UnionManx/CC BY 2.0))

Recipharm faced a classic good news-bad news situation last week. The good news is that a plant slated to close will remain open. The bad news is that U.K. authorities cited a different facility over the potential for cross contamination of products.

The Sweden-based CDMO said that after announcing plans last year to close a plant in Höganäs, Sweden, which handles sachet and stick pack filling, it was approached by several new customers. A contract with one major European drugmaker has now been finalized and others are expected to be completed soon, the company said in an announcement. The decision saves the 45 jobs at the plant

CEO Thomas Eldered said he anticipates volume to grow at the facility through next year. 

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“This has been somewhat unexpected, but we are of course pleased to see new customers entering in Höganäs and that we by this also are able to continue the services to existing customers." Eldered said in a statement.

That news came at about the same time that European authorities posted a Eudra filing showing that a Recipharm plant in Lancashire in the U.K. did not meet GMP standards for manufacturing and packaging of potent products during an inspection in August. U.K. authorities pulled the facility's GMP certificate for potent drugs that are noncritical to the public.

“The site operates separate manufacturing areas for products considered potent and non-potent. In particular, the potential for cross-contamination with highly potent products poses a risk to public health and the National Competent Authority therefore believes that it is necessary in the interests of patient safety to immediately restrict the manufacture of non-critical potent products until the issues are satisfactorily resolved,” the warning read.

The filing said that Recipharm has voluntarily halted production of potent drugs until it can resolve issues but, that regulators believe that formal action is called for until that happens. In a statement, the company said EU authorities have approved its plans for remediation and that it has begun phased shipping of non-restricted products.

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