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

stocks
(PIxabay)

> 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

Webinar

De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools

Wednesday, July 8, 2020 | 11am EST / 8am PST

This webinar will describe strategies to mitigate risks, reduce attrition and help improve the quality and safety of your drug candidate.

> 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

Suggested Articles

Novartis and Civica Rx are patterning up to shore up supply of six key generic injectables used in acute care settings in hospitals.

As Regeneron moves its dual antibody into testing as a COVID-19 preventive, the company scored a hefty supply deal with the Trump administration.

Johnson & Johnson has expanded its COVID-19 vaccine production pact with CDMO Catalent to include work at the manufacturer's Anagni, Italy, site.