Pharma manufacturing news in brief
pharmafile | August 14, 2009 | News story | Manufacturing and Production |Â Â MylanÂ
Pharmafocus' round-up of manufacturing news includes an all-clear for Mylan's Morgantown facility, GSK's flu vaccine plans and updates from the EMEA, PCAS-Nanosyn and Honeyman Group.
Generic drugmaker Mylan says the US Food and Drug Administration report on alleged quality problems at its facility in Morgantown, West Virginia, has concluded with "no deficiencies found and no FDA '483' issued". A report in the Pittsburgh Post-Gazette newspaper last month had suggested there were serious deficiencies at the plant, including a failure to record out-of-specification quality control testing results.
GlaxoSmithKline has said it has allocated 20% of production of H1N1 vaccine at its manufacturing facility in Canada for delivery to developing countries. The move follows criticism by the World Health Organisation and other non-governmental organisations that too much of the world's stockpile of swine flu vaccine will end up in the hands of rich nations. To date the firm says it has orders for nearly 300 million doses of adjuvanted vaccine, which should become available from next month.
The latest version of the European Medicines Agency's EudraGMP database will be available for public access for the first time, in order to provide "more openness and transparency". All the information in the database, with the exception of commercial and personal information that is considered confidential, will be made available. The database contains information on manufacturing and importation authorisations issued by national competent authorities within the EU as well as Iceland, Liechtenstein and Norway.
France's PCAS and Nanosyn of the US have joined forces to operate a kilo-scale development and manufacturing facility in Santa Rosa, California, that will provide active pharmaceutical ingredients (APIs) for preclinical and clinical testing. The facility was formerly operated by Seres Laboratories and was acquired by Nanosyn in March. The joint venture – called PCAS Nanosyn – will be headed up by former Nanosyn executive Olga Issakova.
UK company Honeyman Group has won a contract from South African pharmaceutical firm Aspen to validate a part of the drugmaker's sterile manufacturing process. Honeyman will check the performance of two depyrogenation tunnels, which are used to ensure that packaging, such as vials and syringes, are sterile before they are filled with product and sealed. The contract win was a milestone for the UK firm, which tends to operate within the European market.
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