An FDA inspection of the Zhejiang Huahai Pharmaceutical plant a year ahead of its global recall of tainted valsartan found big problems.
Mylan intends to make operations at its massive West Virginia plant less complex while addressing issues in an FDA Form 483.
An FDA inspector didn’t have to spend long to discover that a Canadian API maker was failing to meet FDA standards.
Samsung BioLogics is slated to get a piece of the $22 billion investment Samsung says it will invest in growth businesses.
A reinspection of Celltrion's South Korea plant resulted in another Form 483, but not a serious one.
The FDA is reporting that the valsartan products may have been on the market for years, not weeks or months.
A blockchain-based drug and vaccine traceability system, which the developer says records all data in the vaccine supply chain, will debut in Shanghai.
A fire at a contract manufacturing facility in New Zealand over the weekend required two dozen crews to extinguish.
Multinational pharma companies have all together closed 16 manufacturing plants in South Korea over the past 20 years, local media reports.
Dogs and cats are now feeling the pain of Pfizer’s manufacturing problems that have contributed to a nationwide shortage of injectable opioids.