Manufacturing licence restriction at Recipharm's Ashton-u-Lyne, UK facility
Following a routine audit, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have restricted the manufacturing licence for five non-critical highly potent products supplied from the Recipharm facility located in Ashton-u-Lyne, UK. This was due to deficiencies in certain of the manufacturing procedures which represented a potential cross contamination risk.
Recipharm’s facility in Ashton-u-Lyne, primarily manufactures non-potent solid dose products. In addition, highly potent products are manufactured in a separate dedicated area.
Following the audit, production was immediately suspended to ascertain the risks and in the meantime the company liaised with the MHRA and customers regarding remediation plans. These plans have been endorsed by the MHRA and are being executed. Supply has recommenced and will continue in a phased manner for the non-restricted products. It is unlikely that this issue will cause significant supply interruptions to patients and it is expected that the licence restriction will be completely lifted by the end of the year.
The financial effect of this issue on Q4 results is anticipated to be less than SEK 10 million.