Warning letters, 483s, Recalls, Import Alerts, Audit observations
Apotex initiated recall of Paroxetine Hydrochloride tablets in US for failed Impurities/degradation Specifications. Apotex Corp.,USA
Sandimmune (cyclosporine oral solution) 100 mg/mL,packaged in 50 mL bottles, is indicated for the prophylaxis
Desmoid tumors are non-cancerous, but locally aggressive and invasive soft-tissue tumors that can lead to
Glenmark has initiated a Class II recall of 37200 bottles of Indomethacin 25mg capsules and
AstraZeneca’s TRUQAP (New Molecule Capivasertib) in combination with Faslodex (Fulvestrant) has been approved in the
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
