Pharma manufacturing news in brief
pharmafile | November 20, 2012 | News story | Manufacturing and Production |Â Â Alfa Laval, Boehringer, Fujifilm, Health Canada, NovartisÂ
Our latest round-up of manufacturing news includes a facility contract for Alfa Laval, plus updates from Fujifilm, Novartis, Boehringer Ingelheim and Health Canada.
Engineering and equipment firm Alfa Laval has won a $13m contract to build an insulin processing line in Malaysia for an undisclosed Indian pharmaceutical company. The project is scheduled for completion in 2014 and involves the supply and installation of equipment for fermentation, fluid handling and tank cleaning.
Fujifilm Diosynth Biotechnologies has won a contract to manufacture ThromboGenics’ vitreomacular adhesion (VMA) treatment Jetrea (ocriplasmin), which was approved for marketing in the US last month. Fujifilm will make the bulk drug substance for Jetrea at its facility in Billingham, UK. It is the second commercial contract awarded to the plant since Fujifilm acquired it from Merck & Co last year.
The Italian authorities have lifted the temporary ban on the use Novartis‘s flu vaccines Agrippal and Fluad, following the lead of the regulatory agencies of Canada and Switzerland. Italy’s AIFA said it took the decision after reviewing information provided by the pharma company on the particulate matter found in vials of the vaccines, as well as its own independent assessment of the vaccines’ safety and efficacy.
Boehringer Ingelheim is recalling a single lot of its anticoagulant Pradaxa (dabigatran) after discovering a packaging defect that could allow moisture to get into the bottle, reducing the effectiveness of the drug. The German firm said the affected lot of Pradaxa 75mg capsules (No. 201900) – which has an expiration date of January 2015 – should be returned to pharmacies for a free replacement.
Health Canada has opened up the public comment period for its amended Good Manufacturing Practice (GMP) guidelines for active pharmaceutical ingredients (APIs), which were published on 29 September. The document is designed to “help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess”, said the regulatory agency, which will take comments until 5 January, 2013.
Phil Taylor
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