Roche has recalled all of its 5-mg Valium blister packs in Australia after uncovering a supply chain breach at a distributor's warehouse.

Earlier this month, the FDA banned all products being shipped to the U.S. by a Chinese API maker, and a new warning letter explains why. It appears the…

Hospitals are dealing with a shortage of sodium bicarbonate, a drug whose active ingredient is essentially the same one that cooks know as baking soda.…

Germany’s Boehringer Ingelheim has opened a €70 million biologics plant in Shanghai to do contract manufacturing targeted at China's growing appetite for…

A manufacturing problem has led to an outage of the 20-mg strength of the tamper-resistant form of the opioid pain drug Zohydro until next year.

The FDA, which banned APIs coming from a Divi’s plant in India, has followed that with a warning letter that savages the facility for a lack of data integrity.

Swiss CDMO Lonza, which has run into FDA concerns about its FDA operations before, has had its cell therapy facility in the U.S. slapped with a warning letter.

Fresenius’ new CEO has pulled off a dealmaking double play, committing more than $5.4 billion to expand its reach in both sterile generics and in biosimilars.

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