The Challenge of Change - Managing Excipients Control
Colorcon
07-Feb-2011 - US Heparin maker Scientific Protein Laboratories (SPL) says it has resolved “many of the issues” addressed in the US Food and Drug Administration (FDA) warning letter it received late last month.
03-Feb-2011 - Sigma-Aldrich has acquired analytical standards and certified reference materials manufacturer Resource Technology Corporation (RTC) to expand its analytical
02-Feb-2011 - The EU and US are using substandard medicines as an excuse to tighten IP rules, boosting pharma profits while making it harder for the poor to access drugs, according to Oxfam.
27-Jan-2011 - Mitsubishi Tanabe Pharma has recalled three lots of injected drugs made at its plant in Ashikaga, Japan after “some aspects of [quality] testing were inadequate.”
26-Jan-2011 - Failure to reduce counterfeiting is one of a number of issues slowing healthcare regulation harmonisation in ASEAN.
25-Jan-2011 - Baxter has shut down a production area at its plant in Castlebar, Ireland, telling the EMA it cannot guarantee peritoneal dialysis (PD) solutions made there are free of endotoxin contamination.
20-Jan-2011 - Teva has confirmed it will cut 200 jobs this year after a voluntary hold was placed on all manufacturing at its Irvine, California, US facility.
19-Jan-2011 - Cambrex’s Hyderabad, India plant has received a GMP compliance certificate, accepted throughout the EU, from the DKMA.
17-Jan-2011 - Solvent selection and solid loading are critical to optimising the spray drying process and unlocking its solubility-enhancing properties for drug production according to a new report by ISP Pharmaceuticals.
13-Jan-2011 - Telstar Group and Puretech Process Systems are teaming up to meet the flood of pharma and biotech demand for water treatment technologies.
13-Jan-2011 - KV Pharmaceutical saw its share price plummet after an FDA delay prompted it to evaluate its liquidity outlook.
13-Jan-2011 - Genzyme has lowered 2011 financial projections after delaying the date it expects Fabrazyme production to return to normal.
12-Jan-2011 - Mobile software developer Wind River says Fedegari Autoclavi has adopted its VxWorks real-time operating system (RTOS) for its Therma4 control systems for its industrial sterilisation machines.
11-Jan-2011 - Thermo Fisher Scientific expects Dionex acquisition to boost global customer base and bolster applied chromatography offering.
10-Jan-2011 - Legislation and resources are needed to support Croatian pharmaceutical regulators in preparation for accession to the European Union (EU).
06-Jan-2011 - in-PharmaTechnologist.com presents a round up of cGMP related warning letters published recently by the FDA.
06-Jan-2011 - Instrument supplier Mocon has taken its business to new heights, literally, by installing two testing units at a Government pharmaceutical laboratory in Lhasa, Tibet.
04-Jan-2011 - GSK says there is no evidence that patients were harmed as a result of production issues at its manufacturing plant in Cidra, Puerto Rico.
04-Jan-2011 - Merck KGaA has opened a new centre in India to showcase its range of technology solutions to the country’s rapidly expanding pharmaceutical and cosmetics industries.
04-Jan-2011 - in-Pharmatechnologist presents a roundup of the latest deals and acquisitions in the pharmaceutical sector with news from Optima, SPI and DPS Engineering.
23-Dec-2010 - Regulations and enforcement were big topics yet again in 2010. in-PharmaTechnologist presents five of our most read on the topics, covering starting material quality and overseas inspections.
22-Dec-2010 - Pfizer is to recall a further 19,000 bottles of Lipitor (atorvastatin calcium) from the US after a customer reported “an uncharacteristic odour”.
22-Dec-2010 - Johnson & Johnson (J&J) dominated recall and quality control (QC) news over the past year but others also faced issues. in-PharmaTechnologist presents five of our most read QC articles of 2010.
16-Dec-2010 - The US FDA said it has found more problems at J&J’s manufacturing facility in Fort Washington, Pennsylvania.
16-Dec-2010 - DSM Pharmaceutical Products has expanded its portfolio of alcohol dehydrogenases in a licensing deal with German custom enzyme developer c-LEcta.