Aurobindo Pharma arm New Jersey facility gets 10 USFDA observations Ruchika Sharma25 Dec 2023 12:22 PM ISTHyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has closed a Pre-Approval...
USFDA issues 6 observations for Zydus Lifesciences Ahmedabad facility Ruchika Sharma23 Dec 2023 11:30 AM ISTAhmedabad: Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has closed the inspection with 6...
USFDA issues EIR for Aurobindo Pharma arm AP facility Ruchika Sharma20 Dec 2023 3:41 PM ISTHyderabad: Aurobindo Pharma has announced that the U.S. Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR)...
Granules Pharma facility gets 5 USFDA observations Ruchika Sharma16 Dec 2023 12:14 PM ISTHyderabad: Granules India Limited has announced that the United States Food and Drug Administration (USFDA) has concluded a GMP inspection...
USFDA inspection: Laurus Labs arm gets 5 observations for AP facility Ruchika Sharma13 Dec 2023 11:18 AM ISTHyderabad: Laurus Synthesis Private Limited (LSPL), a wholly owned subsidiary of Laurus Labs, has received a Form 483 with five observations...
Torrent Pharma gets 5 USFDA observations for Gujarat facility Ruchika Sharma12 Dec 2023 1:06 PM ISTAhmedabad: Torrent Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded the inspection with 5 procedural...
Intas Pharma gets USFDA warning letter due to manufacturing lapses at Ahmedabad plant Ruchika Sharma11 Dec 2023 11:30 AM IST"Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," USFDA said.
Dr Reddy's Labs gets 3 USFDA observations for Bachupally RnD centre Ruchika Sharma9 Dec 2023 10:57 AM ISTHyderabad: Drug major Dr Reddy's Labs, has announced that the United States Food & Drug Administration (USFDA) has issued three...
USFDA issues 3 observations for Alkem Labs Mandva facility Ruchika Sharma2 Dec 2023 11:32 AM ISTMumbai: Through a recent BSE filing, Alkem Labs has informed that the Company has received Form 483 with three observations from the United...
Gland Pharma gets USFDA EIR for Pashamylaram facility Ruchika Sharma25 Nov 2023 11:48 AM ISTHyderabad: Gland Pharma has recently announced that the Company has received an Establishment Inspection Report (EIR) from the US FDA indicating the...
USFDA issues warning letter to Cipla Pithampur facility Ruchika Sharma20 Nov 2023 4:30 PM ISTMumbai: Cipla has announced that the Company has received a warning letter from the United States Food and Drug Administration (USFDA) for the...
USFDA concludes inspection at Aurobindo Pharma arm Unit I, III with zero observations Ruchika Sharma18 Nov 2023 12:30 PM ISTHyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has closed the Pre-Approval Inspection (PAI)...
