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Results For "Facility"

1627 News Found

USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington
Drug Approval | September 11, 2024

USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington

Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding


Evonik starts operation of new spray drying facility for pharmaceutical oral excipients
News | September 11, 2024

Evonik starts operation of new spray drying facility for pharmaceutical oral excipients

Investment in new plant meets increasing demand for functional excipients for oral drug delivery


Granules India’s Gagillapur facility completes USFDA inspection with six observations
Drug Approval | September 09, 2024

Granules India’s Gagillapur facility completes USFDA inspection with six observations

The recent inspection covered both cGMP and PAI processes


Zydus receives warning letter from USFDA for Jarod injectables manufacturing facility
Drug Approval | August 31, 2024

Zydus receives warning letter from USFDA for Jarod injectables manufacturing facility

The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility


Wanbury receives EIR from FDA for Patalganga facility
Drug Approval | August 23, 2024

Wanbury receives EIR from FDA for Patalganga facility

USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation


Atul Bioscience received EIR from USFDA for Ambernath facility
Drug Approval | August 09, 2024

Atul Bioscience received EIR from USFDA for Ambernath facility

The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations


USFDA inspects Gland Pharma’s Dundigal facility
Drug Approval | July 26, 2024

USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations


Unichem gets 5 observations from USFDA for Goa formulation facility
Drug Approval | July 17, 2024

Unichem gets 5 observations from USFDA for Goa formulation facility

The inspection closed with five observations which were more of procedural changes with none of these related to data integrity