FDA Approves New Drug for Pneumonia
FDA has approved Xacduro injection (Durlobactam, a new molecular entity in combination with sulbactam) for
Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has approved Xacduro injection (Durlobactam, a new molecular entity in combination with sulbactam) for
In May 2023 several Injectable products manufactured by Indian Contract Manufacturer Astral SteriTech Pvt. Ltd
USFDA announced implementation of the ICH Q9(R1) guideline Quality Risk Management. Earlier ICH had adopted the Revision
FDA has published the USFDA form 483 issued to Ipca Laboratories Ltd following inspection at