News & Analysis on Clinical Trial Services & Contract Research And Development
API maker AMRI cited arbitration costs, efforts to address a US FDA warning letter and acquisitions as key factors in Q3 loss, but predicted that large-scale contract manufacturing business will drive final quarter gains.
The FDA significantly increased the number of concluded post-marketing requirements and commitments (PMR/PMC) in the 2009 fiscal year, according to a report.
In the 20 month period before the heparin crisis no Chinese producers were inspected by the FDA and efforts during and since have been hindered by legal and practical challenges.
Kendle recorded a 64 per cent drop in Q3 operating income and expects its strategic review of early stage, which will establish a fair value and consider all options, to be complete next quarter.
Novartis says it plans to submit its microchip containing ‘smart-pill’ technology to European regulators within 18 months.
Gerresheimer will open a representative office in Mumbai India this week as part of its growth strategy to capitalise in emerging markets.