manufacturing compliance

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Read the July/August edition of Pharmafocus online now!

June 28, 2019
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NHS, Orkambi, Trump, UK, brexit, generics, manufacturing compliance, pharma

The latest monthly edition of Pharmafocus, the July/August issue, is available to read for free online now!The UK remains split …


Global manufacturing harmonisation: Towards a worldwide safety network

July 2, 2018
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing compliance, feature, manufacturing, manufacturing compliance, pharma

Manufacturing of pharmaceuticals takes place all over the world and the health of patients globally is at stake. Ben Hargreaves …

Gilead manufacturing under investigation by US authorities

June 14, 2011
Manufacturing and Production Department of Justice, Gilead, manufacturing compliance, pharma manufacturing

Gilead Sciences is being investigated by the US authorities over the manufacturing and distribution of some of its products, and …

Teva’s Irvine facility gets FDA green light

May 3, 2011
Manufacturing and Production FDA, Teva, manufacturing compliance

Teva Pharmaceutical Industries has said that an injectables facility in the USA, shut down last April after quality control problems, …

Johnson & Johnson's Tylenol

J&J reorganises McNeil as recalls keep coming

April 5, 2011
Manufacturing and Production J&J, JJ, Johnson & Johnson, McNeil, TBA, TCA, Tylenol, manufacturing compliance, pharma manufacturing, recalls, tribromoanisole, trichloroanisole

Johnson & Johnson has announced a major reworking of its troubled McNeil Consumer Healthcare unit, just as quality problems force …

Novartis gets FDA warning letter for Puerto Rico plant

March 21, 2011
Manufacturing and Production Ciba Vision, FDA manufacturing inspections, Novartis, SoftPerm contact lenses, manufacturing compliance, pharma manufacturing

A manufacturing facility operated by Novartis subsidiary Ciba Vision in Puerto Rico has been cited for manufacturing quality violations and …

J&J charged with US manufacturing violations

March 15, 2011
Manufacturing and Production J&J, JJ, Johnson and Johnson, McNeil Consumer Healthcare, McNeil Fort Washington, McNeil recall, Motrin recall, manufacturing compliance, pharma manufacturing, recalls

Johnson & Johnson subsidiary McNeil Consumer Healthcare has been officially charged with manufacturing and distributing drugs in violation of federal …

Daiichi recalls contaminated paediatric vaccines

March 15, 2011
Manufacturing and Production ActHIB, Daiichi Sankyo, manufacturing compliance, padiatric vaccine recall, recalls, vaccines

Japanese drugmaker Daiichi Sankyo has recalled around 1.3 million doses of the paediatric vaccine ActHIB, manufactured by Sanofi-Aventis, because of …

Quality problems lead to short-term layoffs at Baxter Ireland

February 22, 2011
Manufacturing and Production Dianeal, Extraneal, Ireland, Nutrineal, baxter, job cuts, manufacturing compliance, peritoneal dialysis

A contaminated production line at a facility in Ireland operated by Baxter Healthcare has resulted in 150 staff being laid …

J&J hit by another string of product recalls

February 21, 2011
Manufacturing and Production J&J, JJ, Johnson & Johnson, Simponi, golimumab, manufacturing compliance, pharma recalls

There seems to be no end to the quality troubles plaguing Johnson & Johnson, with several more recalls to report, …

Teva plant in Israel cited by FDA, expands in Americas

February 8, 2011
Manufacturing and Production Corporacion Infarmasa, FDA, Peru, Teva, Teva Pharmaceutical, generics, generics manufacturing, manufacturing compliance

A manufacturing facility in Jerusalem operated by Teva Pharmaceutical failed to pass muster in an FDA inspection, prompting a warning …

Savient plays down gout drug manufacturing problems

January 11, 2011
Manufacturing and Production, Sales and Marketing Krystexxa, Savient, biologic manufacturing, gout, manufacturing compliance, pegloticase

Savient Pharmaceuticals has reported that some production batches of Krystexxa, its recently-approved second-line treatment for gout, have failed to meet …

More US recalls as bill seeks greater FDA powers

January 10, 2011
Manufacturing and Production Centocor Ortho Biotech, Cumberland Pharmaceuticals, FDA, RiteDose Corp, Sandoz, Sigma-tau Pharmasource, Teva Pharmaceuticals, manufacturing compliance, recalls

Product recalls continue to make headlines in the pharmaceutical sector, with several new incidents either side of the New Year …

GSK's UK headquarters

GSK hits back at 60 Minutes whistleblower interview

January 6, 2011
Manufacturing and Production 60 Minutes, Avandamet, Bactroban, Cheryl Eckard, GSK, GlaxoSmithKline, Kytril, Paxil, manufacturing compliance

GlaxoSmithKline has responded to an edition of US current affairs show 60 Minutes centring on manufacturing problems at its now-closed …

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