Warning letters, 483s, Recalls, Import Alerts, Audit observations
Alembic recently initiated recall of antidepressant drug Doxepin Hydrochloride Capsules (10 mg) in US for Nitrosamine
Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability
USFDA has allowed drug manufacturers additional time for submission of mitigation actions and required changes
Authored by: Venkiteswaran.T.K Nitrosamine impurities in pharmaceutical products are a significant concern due to their
Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules
WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in
With timelines closing in for drug product manufacturers to finalize their nitrosamine risk assessments, recalls
Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication,
Glenmark Pharmaceuticals is recalling several lots of the cardiovascular drug Carvedilol in US due to
Adding to the growing number of drug recalls due to NDSRIs in 2024, Glenmark is
