Manufacturing News of Note—Lonza expands cell therapy facility; Mylan recalls anxiety drug


> Mylan is voluntarily recalling more than 10,000 bottles of generic Xanax, saying there is a small risk from a foreign substance. Release

> Lonza says it will expand its Singapore cell therapy operation and use new technology to produce commercial-scale product of an allogeneic cell treatment being developed by Mesoblast the biotech expects to submit to the FDA for review by the end of the year. Release

> The FDA has posted a warning letter to Glenmark that the Indian drugmaker earlier this month reported it had received. Warning letter


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.

> U.K.-based CDMO Sterling Pharma is investing $1.5 million in a plant in Research Triangle Park, North Carolina, that it acquired earlier this year. 

> China’s API maker WuXi Sta say its manufacturing facility in Jinshan in Shanghai has passed a European Medicines Agency inspection. Release 

> There have been shortages in hormone replacement therapy in the U.K. Release 

> CPI and Strathclyde University, in a partnership with GlaxoSmithKline and AstraZeneca, have begun work on a continuous direct compression platform for oral solid dose meds. Story 

> India's Lupin, which has a long list of FDA manufacturing issues, says its plant in Nagpur passed an inspection with no observations. Release

> Taiwanese CDMO Bora, which specializes in complex modified release products, has opened a U.S. office in Delaware. Release