Manufacturing and Production

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J&J faces FDA scrutiny for another manufacturing unit

May 27, 2010 Manufacturing and Production Advanced Sterilization Products, Ethicon, J&J, JJ, McNeil, manufacturing compliance

Another Johnson & Johnson subsidiary has come under scrutiny by FDA for failing to meet quality standards in its manufacturing. …

Genzyme confirms details of consent decree and $175m fine

May 27, 2010 Manufacturing and Production Cerezyme, Fabrazyme, Genzyme, Lumizyme, Thyrogen, manufacturing compliance

Genzyme’s predictions on the penalties levied for the ongoing problems at its manufacturing facility in Allston Landing have been confirmed, …

Eisai opens $100m parenterals plant in North Carolina

May 24, 2010 Manufacturing and Production, Research and Development Aricept, Eisai, eribulin, parenterals

Japanese drugmaker Eisai has opened a 65,000-sq.ft. facility at Research Triangle Park in North Carolina, USA, which will serve as …

Pharma manufacturing news in brief

May 24, 2010 Manufacturing and Production Angel Biotech, Halozyme, Johnson Matthey, Ranbaxy, Sagent Pharmaceuticals, baxter

There are more quality problems to report on the manufacturing beat this week, with recalls for Ranbaxy, Halozyme/Baxter and Sagent …

Pfizer takes the axe to manufacturing operations

May 19, 2010 Manufacturing and Production Pfizer, job cuts, manufacturing

Pfizer is to reduce manufacturing staffing by around 6,000 – around 18% of its total production workforce – and close …

FDA says rotavirus vaccines are safe

May 17, 2010 Manufacturing and Production drug safety, rotarix, rotateq

The US Food and Drug Administration has taken the advice of its advisors and given its backing to resume the …

Pharma manufacturing news in brief

May 10, 2010 Manufacturing and Production American Peptide, DSM Biologics, Dutch CMO SynCo Bio Partners, KV Pharmaceutical, Merck & Co, manufacturing

This week’s round-up of pharmaceutical manufacturing news includes facility updates from KV Pharmaceutical, DSM Biologics, Merck & Co and American …

In search of a real solution to the counterfeit problem

May 10, 2010 Manufacturing and Production Plavix, counterfeits, supply chain

For a great deal of the last decade, warnings from the pharmaceutical industry about the growing threat of counterfeit medicines …

Congress to probe McNeil’s GMP violations

May 7, 2010 Manufacturing and Production Johnson & Johnson, McNeil, manufacturing compliance

The US Food and Drug Administration may take additional regulatory action against Johnson & Johnson subsidiary McNeil Consumer Healthcare over …

EMA appoints Alexis Nolte head of quality

May 7, 2010 Manufacturing and Production EMA, appointment, manufacturing and production

The European Medicines Agency has appointed Alexis Nolte to head up its Quality of Medicines Sector. He was previously principal …

Congress criticises FDA over contaminated heparin case

May 6, 2010 Manufacturing and Production heparin, manufacturing compliance

The US Food and Drug Administration’s follow-up of the contaminated heparin scandal which surfaced in 2008 has been inadequate, according …

Abbott’s Mark Kontny joins Patheon

May 6, 2010 Manufacturing and Production Patheon, appointment, manufacturing and production

Patheon has appointed Dr Mark Kontny president of global pharmaceutical development services and chief scientific officer. He joins the contract …

More quality issues dog J&J

May 5, 2010 Manufacturing and Production Johnson & Johnson, manufacturing compliance, recalls

Johnson & Johnson’s manufacturing is under the spotlight at the FDA once again for quality issues affecting its products. At …

Colorcon buys French excipients specialist

April 30, 2010 Manufacturing and Production Colorcon, Ethypharm, NP Pharm, contract manufacturing, excipients

US-based Colorcon has acquired excipient specialist NP Pharm, a division of French drugmaker Ethypharm, in order to expand its product portfolio …

FDA warns Teva over California plant

April 30, 2010 Manufacturing and Production Teva, manufacturing compliance

Teva has become the latest drugmaker to be rebuked by the FDA for not responding effectively enough to compliance problems …
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