13-Oct-2015 - Want to pass an FDA inspection? Do not answer back, do not volunteer information and do not sign anything, says an ex-auditor and regulatory consultant.
12-Oct-2015 - [View the story "Meds makers meet in Madrid " on Storify]
06-Oct-2015 - The US FDA has issued a product safety alert and recommended a compounding pharmacy cease manufacturing operations after observing unsanitary conditions at a Californian facility.
05-Oct-2015 - The MHRA has signed a Memorandum of Understanding (MOU) with Indian regulators to help ensure the quality of drugs in the UK.
28-Sep-2015 - The US FDA has revoked approval for Sun Pharmaceutical Industries’ extended-release epilepsy drug Elepsia XR over concerns the firm's manufacturing plant in Halol, India does not meet quality standards.
23-Sep-2015 - European regulators and the WHO have begun sharing confidential information about drug applications, quality, and inspections under a new agreement.
23-Sep-2015 - Drugmakers need more certainty and reliabilty around their supply chain in light of increased regulatory vigilance says Mylan, itself carrying out remediation across several Indian facilities.
16-Sep-2015 - Indian API maker Pan Drugs is reconstructing its manufacturing suite after holes in the wall and rusty equipment landed the facility a US FDA warning.
16-Sep-2015 - Illegal internet pharmacies and a desire for cheaper meds mean fake drugs are a problem even in smaller pharmaceutical markets say Estonian regulators.
04-Sep-2015 - An Indian TB drugmaker has been hit with a WHO Notice of Concern but an independent audit carried out by its customer Svizera Europe disputes the GMP violations raised.
27-Aug-2015 - Product problems for Allergan and Danish Leo Pharma, plus the Japanese regulator reviews a Bristol-Myers Squibb mAb.
20-Aug-2015 - Merck & Co. has recalled two chemotherapy products because of cracked caps, including one it manufactures for Novartis’ Sandoz.
19-Aug-2015 - Pakistani pharmaceutical manufacturers are today halting production in protest at changes to manufacturing regulations.
19-Aug-2015 - As it tries to close its biggest deal ever -- a $33bn acquisition of Perrigo -- Mylan is now also dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing facilities in India.
18-Aug-2015 - Teva’s UK business has alerted the regulator that packets of the painkiller and anti-seizure medicine Pregabalin are printed with the wrong dosage.
18-Aug-2015 - As part of European efforts to help stem the spread of counterfeit medicines, the European Commission has laid out the details of a key part of its Falsified Medicines Directive (FMD).
13-Aug-2015 - Manufacturers of excipients are being sent inappropriate requests for stability data by some regulators and pharma companies, threatening to disrupt the supply chain, IPEC claims.
13-Aug-2015 - The GSK site tainted with Legionella bacteria will likely reopen in a few days, the company says.
12-Aug-2015 - GlaxoSmithKline was forced to briefly shutter its Zebulon, NC, manufacturing facility after the company discovered legionella bacteria in one of its cooling towers.
10-Aug-2015 - US politicians have given the NIH and FDA until Friday to answer questions about oversight at a contaminated National Institutes of Health clinical trial manufacturing site.
Butterworth specialise in Quality Control Analysis, Method Development, Validation & Stability Testing of Raw Materials, API, Fini...
Process Analytical Technologies (PAT) in solid dosages forms are commonly used for tablets. Procaps brings to you this webinar in...