Another Chinese product using potentially substandard ingredients has slipped through the regulatory cracks into the U.S.
Privately held Kaléo has a supply of epinephrine auto injectors and is making sure the public knows its version is available.
Roche routinely appeals property taxes over depreciation on its manufacturing equipment at its South San Francisco campus.
The SI Group is expanding ibuprofen production at its plant in Orangeburg, South Carolina, after just completing an expansion this year.
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.
