Warning letters, 483s, Recalls, Import Alerts, Audit observations
Glenmark Pharmaceuticals Inc., USA is recalling one lot of Esomeprazole Magnesium Delayed-Release Capsules. The recall
FDA approves Evive Biotech’s Ryzneuta for the management of chemotherapy-induced neutropenia (incidence of infection, as
Bayer is recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass
Cipla in a statement informed that its Pithampur, Indore facility is issued an USFDA Warning
Merck in a statement announced that FDA’s advisory committee voted 12-1 that Gefapixant do not
USFDA Inspected Indian drug manufacturer Kilitch facility in Mumbai (FEI 3011853060) in Oct 2023. USFDA
Bristol Myers Squibb Augtyro™ (repotrectinib) is approved for treatment of adult patients with ROS1-positive non-small
System sensitivity requirement is limited to impurities where a reporting threshold is specified and Peak
Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI
A WHO-Listed Authority (WLA) is a National Regulatory Authority (NRA) that is recognised as meeting
