Dr Reddy's Denosumab Biosimilar AVT03 Faces USFDA Setback After Plant Inspection Farhat Nasim1 Jan 2026 5:54 PM ISTNew Delhi: Drug major Dr Reddy's Laboratories Limited's wholly owned subsidiary, Dr. Reddy's Laboratories SA, Switzerland, has received a Complete...
Strides Pharma Science arm New York facility gets 4 USFDA observations Ruchika Sharma25 Dec 2025 11:30 AM ISTBengaluru: Strides Pharma Science has announced that the U.S. Food and Drug Administration (USFDA) has concluded inspection with four observations...
Emcure Pharma gets USFDA EIR for Gujarat facility Ruchika Sharma24 Dec 2025 10:30 AM ISTPune: Emcure Pharma has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Gujarat...
Granules India arm gets 5 USFDA observations for Hyderabad facility Ruchika Sharma20 Dec 2025 12:38 PM ISTTelangana: Granules India has announced that the U.S. Food and Drug Administration (FDA) has concluded an inspection with five observations...
USFDA issues EIR for Biocon Generics Cranbury facility Ruchika Sharma19 Dec 2025 11:30 AM ISTBengaluru: Biocon has announced that the Company has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated...
Sun Pharma Baska facility gets OAI status from USFDA Ruchika Sharma18 Dec 2025 2:27 PM ISTMumbai: Sun Pharma has announced that the company has received Official Action Indicated (OAI) status from the U.S. Food and Drug Administration...
Aurobindo Pharma arm Unit IV gets 5 USFDA observations Ruchika Sharma18 Dec 2025 11:30 AM ISTTelangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued five observations at the end of...
Lupin Nagpur injectable facility gets EIR from USFDA Ruchika Sharma17 Dec 2025 11:30 AM ISTMumbai: Global pharma major Lupin Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States...
Aurobindo Pharma arm API facility receives 3 observations from USFDA Ruchika Sharma13 Dec 2025 12:58 PM ISTHyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) concluded the inspection with three...
Dr Reddy's Labs gets 5 USFDA observations for Srikakulam facility Ruchika Sharma13 Dec 2025 12:17 PM ISTHyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has completed a GMP and a...
Granules Life Sciences facility receives EIR from USFDA Ruchika Sharma13 Dec 2025 10:30 AM ISTHyderabad: Granules India has announced that Granules Life Sciences Private Limited, a wholly owned subsidiary of the company situated in...
USFDA inspection: Piramal Pharma receives 4 observations for Lexington facility Ruchika Sharma12 Dec 2025 11:43 AM ISTMumbai: Piramal Pharma has announced that the company has received four observations from the U.S. Food and Drug Administration (USFDA) for...
