14-Dec-2015 - The US FDA has alerted compounders of potential particulate matter in an API sourced from Chinese drugmaker Taizhou Xinyou Pharmaceutical & Chemical.
10-Dec-2015 - A new system will simplify and speed-up US imports of pharma ingredients the FDA says, but industry needs to be on board by the end of February.
09-Dec-2015 - New Delhi industry group ASSOCHAM says international criticism of Indian drug and API plants is due to a ‘severe shortage’ of regulatory inspectors.
07-Dec-2015 - Danaher has bought production line monitoring and coding tech firm Laetus to bolster its life science product ID offering ahead of a planned corporate split next year.
03-Dec-2015 - GSK has delayed the Japanese launch of a male pattern baldness drug after a production halt at a French facility operated by its CMO, Catalent.
02-Dec-2015 - Wockhardt has received a GMP certificate from the UK’s MHRA for its facility in Chikalthana, India.
25-Nov-2015 - Manipulated employee records and English-only training materials were among violations cited by the US FDA at two Indian plants, but Sandoz is confident these will be resolved.
25-Nov-2015 - Restarting production at the former Ben Venue facility in Ohio will be a “significant task” says Xellia Pharmaceuticals which plans to invest after buying the site from Hikma.
25-Nov-2015 - Thermofisher Scientific has stopped selling two agars used in pharmaceutical industry control labs, citing a worldwide shortage of the seaweed used to make them.
17-Nov-2015 - Out-of-place softgel capsules have led to the suspension of manufacturing at a site in France, and Catalent says the problem is almost certainly due to malicious actions.
12-Nov-2015 - The UK regulatory agency is recruiting for medical assessors, but with drug-device combinations, biologics and personalised medicines making the job more complex, do you have what it takes?
12-Nov-2015 - More than one hundred women are suing a subsidiary of Irish manufacturer Endo International, claiming a packaging error caused their contraception to fail and result in unwanted pregnancies.
11-Nov-2015 - The UK biopharma industry is reporting difficulties finding manufacturing workers with the skills to make vaccines, biologics, and advanced therapy medicinal products (ATMP), according to ABPI.
09-Nov-2015 - The over-reaction to quality infringements by Indian drugmakers is part of a “turf war” with Western firms, the Indian Government says.
04-Nov-2015 - While pharma is increasing use of automation and data integration tools in process development and manufacturing, it lags behind in electronic documentation of quality control, according to Lonza Biologics QC director Jessica Jean.
04-Nov-2015 - Inconsistent tablet colour and issues with compressing procedures have landed Indiana OTC maker American Family Pharmacy (AFP) with a US FDA warning letter.
03-Nov-2015 - Pfizer says there were no safety or quality problems with the drugs made at the Chinese site reportedly issued with a 483 for expired materials and missing paperwork.
26-Oct-2015 - A GlaxoSmithKline plant in China that was hit by an explosion in the summer has had its Good Manufacturing Practice (GMP) certificate revoked by the UK medicines regulator.
20-Oct-2015 - The US FDA has issued an alert warning the public not to take drugs marked as sterile by compounding firm Qualgen.
20-Oct-2015 - EMD Millipore will offer drugmakers two-years of unlimited access to its suite of raw materials dossiers for 20,000€ as part of its enhanced portfolio offering.
The International Conference of Harmonisation (ICH) guidance document on elemental impurities, Q3D, reached step 4 in December 2014, m...