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FDA wary of West-Ward warning letter’s effect on drug shortages

The US FDA has sent West-Ward Pharmaceuticals a warning letter and asked for forewarning of any actions that may worsen drug shortages.

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Hospira aims for 2H ramp up at NC plant but challenges ahead

Hospira hopes to ramp up output at its Rocky Mount facility in the second half of 2012 but warned it is “very difficult” to predict the remediation timeline.

People on the move: jobs in pharma

in-PharmaTechnologist presents its weekly round-up of the latest appointments in the pharmaceutical industry, including news from Silence Therapeutics, Accorda, and Hospira.

FDA warning letter asks Merck KGaA to investigate all its sites

The US FDA expects Merck KGaA to do a “comprehensive and global assessment” of its sites after sending a warning letter to three plants.

Quality regulations lag behind modern understanding; FDA

Regulations have failed to keep pace with modern understanding about manufacturing and quality, a FDA director said.

Global Industry News

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Asymchem plans investments to further expand new China plant from Outsourcing-Pharma.com

CMO Asymchem Laboratories will invest $12m (€9m) in its new China manufacturing facility to add downstream capabilities.

Quintiles expands its commercial services footprint from Outsourcing-Pharma.com

Quintiles has added to its commercial services capabilities in the Middle East and North Africa (MENA) region through an agreement with UAE-based Dayarn Pharma.

Icon earnings miss guidance as cost rise outstrips sales uptick from Outsourcing-Pharma.com

Fourth quarter earnings at Icon missed analyst estimates and its guidance as an uptick in sales failed to offset rising costs.

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