Pharma manufacturing news in brief
pharmafile | May 24, 2010 | News story | Manufacturing and Production | Angel Biotech, Halozyme, Johnson Matthey, Ranbaxy, Sagent Pharmaceuticals, baxter
There are more quality problems to report on the manufacturing beat this week, with recalls for Ranbaxy, Halozyme/Baxter and Sagent Pharmaceuticals, but good news on the contracts front for CMOs Johnson Matthey and Angel Biotech.
Daiichi Sankyo subsidiary Ranbaxy Laboratories has said its European subsidiary is recalling batches of three of its products, including the antidepressants mirtazapine and sertraline, from the UK, Ireland and Denmark because they need safety information updates on the labelling. Ranbaxy is already struggling to bring manufacturing facilities in India and the US into line with Good Manufacturing Practices (GMP), but said there are no quality issues with the products themselves in this European recall.
Halozyme has been forced to recall batches of its paediatric rehydration product Hylenex (hyaluronidase human injection) after discovering flakes of a glass-like material in a number of vials which is thought to originate from closure system or some other element of the fill-and-finish process. The product is finished by Baxter, and Halozyme has said that if Baxter cannot remedy the breach it may end the contract.
Sagent Pharmaceuticals has voluntarily recalled all lots of metronidazole 500mg/ml injection product, made by contract manufacturer Claris Life Sciences, after discovering that two lots were not sterile. Metronidazole is an intravenous antibiotic, and the company warned that use of non-sterile material could lead to potentially fatal infections. The affected lots were distributed to wholesalers, distributors and hospitals between February and May.
US drug developer KemPharm has entered into an exclusive supply agreement with Johnson Matthey for the manufacture of the active pharmaceutical ingredient KP201, KemPharm’s novel hydrocodone prodrug for acute pain which is due to start clinical testing later this year. Under the terms of the agreement, KemPharm will be responsible for preclinical and clinical studies development of the drug candidate, while Johnson Matthey will be responsible for manufacturing the API.
Angel Biotechnology of the UK has signed three contracts with Materia Medica Holding, a Russian pharmaceutical company, for regulatory consultancy services. The new contracts relate to antibody manufacturing currently ongoing at Angel and have a total value of around £330,000 ($475,000)). In a statement, Angel’s chief operating officer Gordon Sherriff said the contracts endorse the company’s strategy of offering regulatory services alongside process development and manufacturing.
Phil Taylor
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