Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Gilead announced FDAs approval of Livdelzi (Seladelpar) for treatment of PBC, a rare, chronic, autoimmune
The USFDA has announced the fiscal year (FY) 2025 rates for GDUFA III fees. The
South Korean Drug Regulator MFDS imposed administrative penalties on GlaxoSmithKline (GSK), reports Korea Bio Medical
Zydus Pharmaceuticals (USA) Inc initiated recall of multiple lots of Verapamil Hydrochloride injection due to
CDSCO has published list of drugs which were found to be not of standard quality
Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance
