EC does not expect US FDA to reduce inspections during shutdown
The US Government shutdown is unlikely to reduce US Food and Drug Administration (FDA) inspection activity according to the European Commission.
The US Government shutdown is unlikely to reduce US Food and Drug Administration (FDA) inspection activity according to the European Commission.
Update
Preclinical CRO Cyprotex has set up a laboratory at a former AstraZenca R&D facility that ceased drug development operations earlier this year.
Aspen has acquired a Dutch API plant from MSD and a French sterile production site from GSK.
Indian drug manufacturer Aarti Drug Limited was hit with a warning letter from the US FDA this summer after the agency found multiple cGMP violations.
The US government is set to shut down at least temporarily and the US FDA will see about half of its staff furloughed.
Kemwell says it hopes to attract more Western customers following the first development and manufacture contract from its new Indian facility.