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manufacturing compliance

Showing 15 posts of 60 posts found.

Pfizer expands Lipitor recall

December 24, 2010
Manufacturing 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 …

News

Congressman says FDA should scrutinise J&J’s manufacturing partners

December 21, 2010
Manufacturing 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 …

News

Millions more OTC products recalled by J&J

November 29, 2010
Manufacturing 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 …

News

CP Pharma gets FDA warning for Wrexham facility

November 18, 2010
Manufacturing 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 …

News

FDA slaps import ban on Claris Life Sciences

November 16, 2010
Manufacturing 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 …

News

Genzyme again snubs suitor Sanofi

November 10, 2010
Research 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 …

News

Another US heparin recall for OSCS contamination

November 5, 2010
Manufacturing and Production API, B. Braun Medical, heparin, manufacturing compliance, recalls

US pharmaceutical company B.

News

Pfizer pulls more Lipitor over odour problem

November 2, 2010
Manufacturing 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 …

News

BMS faces approval block unless GMP issues are resolved

November 2, 2010
Manufacturing 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 …

News
GlaxoSmitKline's headquarters

GSK makes record whistleblower payout

October 28, 2010
Manufacturing 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, …

News

Shared API inspections project gains traction

October 26, 2010
Manufacturing 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 …

News

FDA warns Gilead over contamination risks at California facility

October 25, 2010
Manufacturing 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 …

News

J&J chief admits mistakes at Congressional hearing

October 1, 2010
Sales 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 …

News
FDA director of manufacturing and product quality Rich Friedman

The FDA Interview: Is pharma getting worse at manufacturing?

September 29, 2010
Manufacturing 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 …

Feature
Biotech company Amgen's headquarters

Glass flakes lead Amgen to order Epogen and Procrit recall

September 27, 2010
Manufacturing 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 …

News
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