Warning letters, 483s, Recalls, Import Alerts, Audit observations
Aurobindo’s Eugia SEZ Pvt. Ltd at Polepally Village, Mehaboob Nagar, Telengana was inspected by USFDA
FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)
Indian Pharma company Orchid Pharma’s New Molecular Entity (NME) Enmetazobactam gets USFDA approval for treatment
USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI
Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb
The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations
In a Class 3 recall Teva initiated recall of one lot each of Nortrel and Nortrel
Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD
European Pharmacopoeia Commission (EPC) approved the new strategy for N-nitrosamine impurities in individual monographs in
Natco Pharma initiated a recall of one lot of Lanzoprazole 15mg capsules in US. Reason
