The QMN Weekly Bulletin

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finished-product tests if they can link in-process controls to critical quality attributes, according to a new FDA draft guidance.

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).

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.

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.

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

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

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.

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

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.