Lupin receives USFDA observations for two Pithampur manufacturing units Ruchika Sharma18 July 2025 11:57 AM ISTMumbai: Pharma major Lupin has received multiple observations from the U.S. Food and Drug Administration (USFDA) following inspections at two of...
Shilpa Medicare Dabaspet unit gets VAI classification from USFDA Ruchika Sharma16 July 2025 12:14 PM ISTKarnataka: Shilpa Medicare Limited has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI)...
Emcure Pharma Ahmedabad oncology facility concludes USFDA inspection with no observations Ruchika Sharma10 July 2025 11:45 AM ISTPune: Emcure Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded a Pre-Approval Inspection (PAI) at...
USFDA issues 1 observation for Granules Pharma USA facility Ruchika Sharma28 Jun 2025 11:16 AM ISTHyderabad: Granules India has announced that the U.S. Food and Drug Administration (US FDA) has issued one 483 observation after a...
SMS Pharma successfully completes USFDA inspection at Telangana Central Laboratory Analytical Services Ruchika Sharma26 Jun 2025 9:15 AM ISTTelangana: SMS Pharma has announced the second successful completion of the United States Food and Drug Administration (USFDA) inspection at its...
Gland Pharma Visakhapatnam facility gets USFDA EIR Ruchika Sharma24 Jun 2025 11:15 AM ISTHyderabad: Gland Pharma, a generic injectable & ophthalmic focused pharmaceutical company, has announced that the Company has received...
Unichem Labs Roha facility gets 3 USFDA observations Ruchika Sharma23 Jun 2025 12:19 PM ISTMumbai: Unichem Labs has announced that the United States Food and Drug Administration (USFDA) has issued three observations after the inspection...
Granules India Bonthapally API facility gets 1 USFDA observation Ruchika Sharma20 Jun 2025 6:14 PM ISTHyderabad: Granules India has announced that the Company's Bonthapally API Unit-I facility has concluded a U.S. Food and Drugs...
USFDA inspection: Natco Pharma gets 7 observations for Kothur Pharma Division Ruchika Sharma20 Jun 2025 11:31 AM ISTHyderabad: Natco Pharma Limited has announced that the U.S. Food and Drug Administration (FDA) has concluded an inspection with seven...
Zydus gets 2 USFDA observations for Ahmedabad oncology injectable site Ruchika Sharma19 Jun 2025 10:54 AM ISTAhmedabad: Zydus Lifesciences has announced that the US Food and Drug Administration (USFDA) has issued two observations for the...
Alembic Pharma gets USFDA EIR for API III facility at Karakhadi Ruchika Sharma18 Jun 2025 12:38 PM ISTVadodara: Alembic Pharmaceuticals Limited has received Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA)...
Syngene International gets USFDA EIR for Bengaluru GMP manufacturing facilities Ruchika Sharma16 Jun 2025 10:15 AM ISTKarnataka: Syngene International has announced that the Company has received Establishment Inspection Report (EIR) from US Food and Drugs...
