Warning letters, 483s, Recalls, Import Alerts, Audit observations
Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has
Chinese OTC Manufacturer Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd was inspected by USFDA in March
USFDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug
FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at
The USFDA has published a new guidance titled “Review of Drug Master Files in Advance
CDSCO has published list of sixtyseven Drugs & Medicinal products as Not of Standard Quality
CDSCO has published list of drugs declared as spurious in the month of September 2024.
Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities.
USFDA has approved Inavolisib ((Itovebi) of Genentech in combination with palbociclib and fulvestrant, for the
The European Medicines Agency (EMA) has initiated a review of finasteride and dutasteride due to
