After months of deliberations, a court in Iowa has opted to fine contract manufacturing company Cambrex $6,000 for safety violations after an explosion at its facility in Charles City.
Indian pharmaceutical companies are making their first forays in the biotechnology arena, helping the market expand from a standing start at the beginning of the decade to reach a value of $2bn in 2006-7, according to a recent report from KPMG.
Active pharmaceutical ingredient specialist Calyx Chemicals and Pharmaceuticals is planning an acquisition within the next two years, probably in the US or Europe, according to chief executive Smitesh Shah.
Outsourcing-Pharma.com presents its latest round-up of new appointments, employment moves and personnel news in the pharmaceutical contract services sector.
India’s contract manufacturing market is expected to rocket forward over the next couple of years to reach a value of $2.46bn in 2010, according to a just-released report from KPMG.
Canada’s Patheon put in another quarter of robust revenues growth in its third quarter, which coupled with cost-reduction measures helped the firm trim its net loss to $14.7m, down 75 per cent on a year ago.
Canada’s PharmEng International almost tripled its turnover in the second quarter, as its acquisition of a Pfizer manufacturing facility at the end of 2007 transformed sales at contract manufacturing facility Keata Pharma.
Exclusive interview with Bilcare CSO Dr Praful Naik
Executives in pharmaceutical companies tasked with implementing an anti-counterfeiting strategy already have a difficult job assessing a frankly bewildering array of technological solutions.
Lonza hopes that the new business it has set up in China will help cement its position as a leading provider of services to the country’s pharmaceutical manufacturing sector.
Lonza of Switzerland is reaping the benefit of a shift away from bulk chemicals and towards custom manufacturing of high-value pharmaceuticals with a 13 per cent hike in sales in the first half of the year.
Outsourcing-Pharma.com presents its periodic round-up of personnel changes in the pharmaceutical outsourcing arena, with senior appointments at Bristol-Myers Squibb, Parexel and GVK Bio, amongst others.
Pharmaceutical companies in the developed world have already
shifted substantial manufacturing and clinical trial work to
emerging economies such as China and India, but a new study suggest
they are increasingly counting on these...
Sartorius Stedim Biotech has teamed up with Wuxi AppTec to help
companies remove some of the strain of carrying out viral clearance
testing, which for large biopharmaceutical companies can carry a
price tag of up to $1m a year.
Canadian contract manufacturer and consultancy firm PharmEng
International has published its 2007 accounts, and says it remains
firmly focused on getting into the black in 2008.
China's Wuxi PharmaTech saw revenues race away across its divisions
in the first quarter of 2008, benefitting from the continued shift
towards outsourcing of manufacturing and laboratory functions by
the pharmaceutical industry.
Overall, 2007 was another stellar year for contract service
providers, particularly those at the early-stage end of
development, although companies are advised to watch out for a
tougher environment ahead.
More details have emerged over the US Food and Drug
Administration's (FDA's) failure to vet the Chinese manufacturing
plant implicated in the Baxter heparin scare - the agency mistook
it for an already-inspected plant, it...
Questions are hanging over the role of a Chinese manufacturing
facility in the Baxter heparin scare after it has emerged that the
US Food and Drug Administration (FDA) has never inspected the
facility.
Four of India's biggest vaccine manufacturers have had their
licenses suspended by the Indian government after failing to meet
good manufacturing practise (GMP) requirements, according to local
media reports.
Product recalls in the UK due to health and safety concerns have
shot up to their highest level, with the rise in outsourcing to
China finger pointed for much of the blame.
UK-based William Ransom & Son has been advised to voluntarily
recall certain products following a false contamination scare at
its Witham, Essex, facility.
GVK Bio has reinforced its claim to be India's top contract
research organisation with a 100-crore ($25m) push from a private
investment company. The funds will be used to expand its drug
discovery services and push further into...
Discovery Laboratories could see the end of its struggle to launch
its Surfaxin (lucinactant) drug on the US market as it has finally
resolved the manufacturing issues that have plagued the product for
months.
GlaxoSmithKline (GSK) and Merck Sharp & Dohme (MSD) have made
further moves in their plans to boost their presence in Singapore,
a region growing in popularity for biopharmaceutical research and
manufacture.
PerkinElmer has expanded its multi-vendor service offering to help
firms reduce the cost of regulatory compliance in pharmaceutical
drug development and manufacturing quality control laboratories.
China has announced an initial $1.7bn investment to bolster its
currently questionable ability to effectively monitor the quality
of the food and drugs manufactured within its borders.
The US Food and Drug Administration (FDA) has released a draft
guideline document outlining a model for implementing the
International Conference on Harmonization's (ICH) Q10.
An online database detailing information on all manufacturing and
importation certificates and authorisations issued within the
European medicines network has been launched by the European
Medicines Agency (EMEA).
AAIPharma has announced it has signed a contract manufacturing
agreement with Mallinckrodt Pharmaceuticals Outsourcing which aims
to provide a "one-stop drug development solution" for drug makers.
Pharmaceutical companies are beginning to catch up with other
industry sectors that take an increasingly realistic view of what
they consider a core competency and outsourcing what is left -
Outsourcing-Pharma takes a snapshot of...
Minimising the risk of cross-contamination in the production of
medicines for use in clinical trials is a major challenge for
manufacturers, who need to implement safety measures in order to
avoid production failure.
GE Healthcare has launched a new contract offering that it claims
will cut the cost of running the service operations in life science
R&D labs by up to 20 per cent, at a time when pharma and
biotech firms are facing intense cost...