manufacturing compliance
Pfizer expands Lipitor recall
December 24, 2010Manufacturing and Production Lipitor, Pfizer, manufacturing compliance, recalls
Pfizer has been forced to recall another 19,000 bottles of its cholesterol-lowering drug Lipitor in the US after consumers reported …
Congressman says FDA should scrutinise J&J’s manufacturing partners
December 21, 2010Manufacturing and Production BestSweet, FDA, J&J, JJ, Johnson & Johnson, McNeil, Rolaids, manufacturing compliance, recalls
The latest flurry of recalls from Johnson & Johnson has prompted additional calls for a wide-ranging investigation of the company’s …
Millions more OTC products recalled by J&J
November 29, 2010Manufacturing and Production Benadryl Allergy Fastmelt, J&J, JJ, Johnson & Johnson, Motrin, Rolaids, Tylenol, manufacturing compliance, recalls
Johnson & Johnson has been forced to announce yet another recall of over-the-counter medicines manufactured at its Fort Washington facility …
CP Pharma gets FDA warning for Wrexham facility
November 18, 2010Manufacturing and Production CP Pharmaceuticals, FDA, FDA warning letter, Wockhardt, manufacturing compliance, pharma manufacturing
UK drugmaker CP Pharmaceuticals is the latest to receive a warning letter from the FDA for failing to meet standards …
FDA slaps import ban on Claris Life Sciences
November 16, 2010Manufacturing and Production Ahmedabad, Claris Life Sciences, FDA, GMP, GMP violations, Good Manufacturing Practice, Ranbaxy Pharmaceuticals, manufacturing compliance
Indian drugmaker Claris Life Sciences has been prohibited from importing products into the US after manufacturing quality problems emerged at …
Genzyme again snubs suitor Sanofi
November 10, 2010Research and Development, Sales and Marketing Campath, Chris Viehbacher, Genzyme, Henri Termeer, Orphan Drugs, Plavix, Sanofi, Sanofi-Aventis, manufacturing compliance
Genzyme has once again snubbed Sanofi-Aventis as the French pharma firm continues its pursuit of the beleaguered biotech company. Henri …
Another US heparin recall for OSCS contamination
November 5, 2010Manufacturing and Production API, B. Braun Medical, heparin, manufacturing compliance, recalls
US pharmaceutical company B.
Pfizer pulls more Lipitor over odour problem
November 2, 2010Manufacturing and Production Lipitor, Lipitor recall, Pfizer, manufacturing compliance, recalls
Pfizer has widened its Lipitor recall after yet another incident in which consumers reported a musty smell emanating from bottles …
BMS faces approval block unless GMP issues are resolved
November 2, 2010Manufacturing and Production BMS, Bristol-Myers Squibb, FDA, Puerto Rico, belatacept, manufacturing compliance, pharma manufacturing
Bristol-Myers Squibb has been threatened with a block on approvals of certain new drugs, including a biologic for preventing organ …
GSK makes record whistleblower payout
October 28, 2010Manufacturing and Production Cheryl Eckard, FDA, GSK, GlaxoSmithKline, manufacturing compliance, whistle blower
GlaxoSmithKline has officially agreed to plead guilty to distributing adulterated drugs made at its now-closed facility in Cidra, Puerto Rico, …
Shared API inspections project gains traction
October 26, 2010Manufacturing and Production API, EDQM, EMA, FDA, TGA, manufacturing compliance, pharma manufacturing, regulatory affairs, regulatory inspections
A three-way initiative between regulatory authorities in the EU, US and Australia on the inspection of facilities making active pharmaceutical …
FDA warns Gilead over contamination risks at California facility
October 25, 2010Manufacturing and Production AmBisome, Cayston, FDA, Gilead, Macugen, Viread, manufacturing compliance, pharma manufacturing
Gilead Sciences has been sent a warning letter from the FDA after failing to rectify problems at a facility used to …
J&J chief admits mistakes at Congressional hearing
October 1, 2010Sales and Marketing Johnson & Johnson, manufacturing compliance, recalls
Johnson & Johnson chief executive William Weldon admitted yesterday that his company had failed to maintain quality standards and mishandled …
The FDA Interview: Is pharma getting worse at manufacturing?
September 29, 2010Manufacturing and Production, Research and Development FDA, manufacturing, manufacturing compliance
It seems that barely a week goes by at the moment without news of another pharmaceutical company falling foul of …
Glass flakes lead Amgen to order Epogen and Procrit recall
September 27, 2010Manufacturing and Production Amgen, Centocor Ortho Biotech, Epogen, Procrit, manufacturing compliance, recalls
Amgen has taken what it describes as a precautionary measure and recalled lots of two of its erythropoietin-based products Epogen …
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