The Challenge of Change - Managing Excipients Control
Colorcon
20-Jul-2011 - Filtration, separation and purification technology company Pall is to acquire its long-time Brazilian distribution partner, Engefiltro.
20-Jul-2011 - Clinical trials of a monoclonal antibody produced in transgenic tobacco plants, a potentially low-cost, scalable system, have begun in Europe.
19-Jul-2011 - Hong Kong is considering legal action against GSK after antibiotic samples were found to contain plasticisers.
18-Jul-2011 - Europe has proposed draft distribution guidance in response to globalisation and threats to the pharmaceutical supply chain.
13-Jul-2011 - The FDA is offering a grant to research projects that improve the reliability, speed and quality of biopharm production processes.
13-Jul-2011 - Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report.
11-Jul-2011 - Generic drug production is on the up in animal heath care.
11-Jul-2011 - Developments in the field of Chinese Hamster Ovary (CHO) based biomanufacturing this week with new products from SAFC and BD Biosciences.
11-Jul-2011 - Production plants exceeding emission levels could have manufacturing authorisations revoked under EU GMP proposals made by Sweden.
11-Jul-2011 - Eli Lilly has called for law enforcement to find and dismantle the supply sources and distribution networks underpinning fake online pharmacies.
07-Jul-2011 - The FDA has sent a warning letter to Cadila Healthcare’s Ahmedabad, India finished products plant after an inspection found GMP deviations.
07-Jul-2011 - Tylenol Extra Strength Caplets yesterday became the latest in a long succession of Johnson & Johnson products to be pulled from the shelves after complaints of the pills’ “musty odor”.
07-Jul-2011 - The US Food and Drug Administration (FDA) has followed up a warning letter by banning imports from Dr Reddy’s Mexican API plant.
06-Jul-2011 - US Government Officials have implored ten major pharmaceutical companies to give up information in the race to solve the 2007-2008 contaminated Chinese herparin incident.
04-Jul-2011 - The USP has published a free, online collection of standards to support drug quality, particularly where regulatory resources are limited.
29-Jun-2011 - DSM Biologicals has launched a new production method designed to streamline downstream processing during biopharmaceutical manufacturing that, it claims, makes making mAB-based drugs more cost effective.
28-Jun-2011 - Australia’s CSL Biotherapies has received a warning letter from the US FDA for GMP deviations at its vaccine production plant in Parkville, Victoria.
22-Jun-2011 - The FDA has outlined its plan to ensure the quality of products imported into the US, including working more closely with regulators and industry.
21-Jun-2011 - The EMA has proposed to the FDA that European inspections of US manufacturing plants are waived when certain criteria are met.
21-Jun-2011 - Processing technology firm Pall Life Sciences has introduced a 200L version of its Allegro single-use mixer for biopharmaceutical manufacturing.
20-Jun-2011 - Dr Reddy's Mexican API production plant has received an FDA warning letter that details failures to validate analytical methods and other problems.
16-Jun-2011 - SGS Life Sciences Services testing received WHO prequalification as a centre for pharmaceutical quality analysis has laboratory in Belgium.
13-Jun-2011 - Sales to the biopharmaceutical sector drove revenue growth at Pall in third quarter fiscal 2011 and will be key to the firm’s future says CEO.
13-Jun-2011 - Symetic has opened a new lab facility to showcase its range of processing systems to the pharmaceutical manufacturing, packaging and nutraceutical sectors.
09-Jun-2011 - Portugal-headquartered API manufacturer Hovione has teamed up with Particle Sciences (PSI) to tackle the issue of poor drug solubility.