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Theqmnweeklybulletin

April 18, 2008

Vol. 2 No. 16

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FDA Details Manufacturing Expectations in Stent Guidance

Manufacturers of drug-eluting stents may not have to perform certain finished-product tests if they can link in-process controls to critical quality attributes, according to a new FDA draft guidance. Read More

Heparin Scare Tests FDA’s Drug Quality Agreement With China

The FDA’s memorandum of agreement (MOA) with Chinese regulators was put to the test during its investigation into adulterated batches of Chinese-made active pharmaceutical ingredient (API). Read More

USP Modifies Glycerin Monograph: More Requirements for Pharma

The U.S. Pharmacopeial (USP) Convention has updated its monograph for glycerin to require manufacturers using its standards to prove that pharmaceutical preparations are free of diethylene glycol. Read More

AstraZeneca Settles Row With Ranbaxy

AstraZeneca, UK’s second largest drug maker, on Tuesday announced an out-of -court settlement with Ranbaxy Laboratories on a pending patent infringement litigation on its heartburn drug esomeprazole. Read More

Drugmaker Announces up to 500 Job Cuts

Drugmaker Eli Lilly and Co. announced that it will be cutting as many as 500 jobs at its plant in Indianapolis. Read More

Alcon to Build Plant in Singapore

Alcon Inc. said it plans to build a facility in Singapore that will manufacture pharmaceuticals to be distributed throughout most of Asia. Read More

Sanofi Secures Deal to Supply Plavix to U.S.

Following a [$196.89 million] investment in its Newcastle manufacturing plant, a global pharmaceutical company has secured the right to supply the U.S. market with a drug made on Tyneside – for the first time. Read More

EMD Serono Plans $50 Million Expansion

Add EMD Serono Inc. to the growing list of drug companies expanding in Massachusetts. Read More

Wright Medical Doubling Manufacturing Space

Wright Medical Group, Inc. is investing $15 million-$20 million in a construction project that will add 67,000 square feet, a new building and office renovations to its Arlington [Tennessee] campus. Read More