Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations
Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules
USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the
WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in
The Central Drugs Standard Control Organisation (CDSCO) has published the NSQ (Not of Standard Quality)
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP
Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US
