Warning letters, 483s, Recalls, Import Alerts, Audit observations
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
USFDA Warning letter to Australian API manufacturer cites basic laboratory compliance issues – Inadequate OOS
USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,
Natco Pharma is recalling one more lot of Lanzoprazole 15 mg delayed release capsules for
The USFDA released draft guidance on New Dietary Ingredient Notification (NDIN) Master Files for dietary
Glenmark has initiated a recall of one lot of Diltiazem Hydrochloride 120mg, Extended Release(ER) Capsules
FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC
FDA approved Akebia’s Vafseo (Vadadustat) for treatment of anaemia due to Chronic Kidney Disease (CKD)
FDA has approved Merck’s Biologic drug Winrevair (Sotatercept-CSRK) for Pulmonary Arterial Hypertension (PAH). The product
Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles
