Warning letters, 483s, Recalls, Import Alerts, Audit observations
CDSCO has published an update on the Spurious and Misbranded drugs in September 2024. Medicinal
CDSCO has published alert of list of drugs Not of Standard Quality (NSQ) identified during
FDA has issued an Updated Guidance for Control of Nitrosamines in Human Drugs in September
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
The European Commission (EC) revoked the conditional marketing authorization (CMA) of Advanz Pharma’s Ocaliva (obeticholic
CDSCO has published a drug alert regarding voluntary recall of Tisseel Lyo Fibrin Sealant VHS/D
CDSCO has published the NSQ (Not of Standard Quality) alert for July 2024. The list
Dr.Reddy’s laboratories Inc (DRL) has initiated recall of 50 batches of Ibuprofen tablets in US
FDA has given approval for Janssen’s New Molecular Entity Lazertinib (Lazcluze). Approval is accorded for
Latest circular issued by CDSCO on Good Distribution Practices (GDP) indicate that the guidance on
