Manufacturing licence restriction at Recipharm Ltd, 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.
Thomas Eldered, CEO, telephone: +46 8 602 52 10
Tobias Hägglöv, CFO, firstname.lastname@example.org, +46 8 602 52 00
This information is information that Recipharm AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, on 25 October 2018, at 13:00 CET.
Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) in the pharmaceutical industry employing around 6,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharmaceutical product development. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. Recipharm’s turnover is approximately SEK 6.0 billion and the company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. The Recipharm B-share (RECI B) is listed on Nasdaq Stockholm.
For more information on Recipharm and our services, please visit www.recipharm.com