Hospira woes continue as GSK sues over quality failures
pharmafile | March 5, 2013 | News story | Manufacturing and Production |Â Â GSK, HospiraÂ
The difficulties besetting generic firm and contract manufacturer Hospira have taken a new turn with the news that one of its customers – GlaxoSmithKline – is suing it for supplying poor quality materials.
GSK is seeking $25 million in damages from Hospira – plus interest and legal fees – because flu vaccines supplied by Hospira over the course of its contract, which extended from 2010 to 2012 but was due to continue until 2015.
The lawsuit is brought by GSK’s Belgian subsidiary GSK Biologicals and is being heard in the District Court for Southern New York in the US, according to Bloomberg.
The news comes at a tricky time for Hospira, which has just announced another three recalls of five separate products made at the company’s troubled plant in Rocky Mount, North Carolina, right in the midst of an FDA inspection.
Among the problems prompting the recalls are visible particles in vials of propofol anaesthetic, plus packaging defects for diazepam, furosemide, morphine sulfate and succinylcholine chloride products which could have allowed contamination.
Meanwhile, adding to the instability at the company, chief scientific officer Sumant Ramachandra has resigned from the position he has held since 2008.
Aside from Rocky Mount, Hospira has other plants under scrutiny by regulators – including facilities at Clayton in North Carolina and Austin in Texas – and brought in external consultants last year to help with remediation efforts. Another facility in Lake Forest, Illinois, was also affected by compliance issues but passed an FDA inspection last year.
Analyst Savvas Neophytou at Panmure Gordon suggested that the newsflow from Hospira could benefit rival company Hikma, which has just announced it has been approached by parties interested in acquiring its injectables business.
Hospira’s troubles could boost the value of Hikma’s business to around $2.2 billion, he added, having earlier put unit’s worth at around $1.6 billion.
Phil Taylor
Related Content
GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis
GSK’s Exdensur (depemokimab), a twice-yearly biological medicine, has received approval from the UK Medicines and …
Multiple myeloma treatment approved in Japan
GSK’s Blenrep (belantamab mafodotin) combinations have been approved by Japan’s Ministry of Health, Labour and …
US FDA expands Jemperli (dostarlimab-gxly) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer as the first and only immuno-oncology-based treatment to show an overall survival benefit
PHILADELPHIA–GSK plc today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination …
