Warning letters, 483s, Recalls, Import Alerts, Audit observations
Glenmark Pharmaceuticals is recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10
FDA has issued final guidance on Circumstances that constitute Delaying, Denying, Limiting, or Refusing a
USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate
EDQM has published the draft guideline on Content of the dossier for sterile substances for
The guidance provides information on how FDA decides goal dates for a drug application (ANDA,
Eugia US LLC is recalling two more injectable products in US for failed impurities, degradation
The scientific community mourns the loss of Dr.Akiro Endo, whose death was announced by the
USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site
Glenmark recalled several lots of Rizatriptan Benzoate Tablets and Rizatriptan Benzoate Orally Disintegrating Tablets in
Elanco Animal Health announced that the USFDA has completed its comprehensive, multi-year review of Bovaer
