Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore
Danish Pharma firm Ascendis Pharma announced the European Commission approval for palopegteriparatide (Yorvipath), for treatment
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
