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Results For "facility"

1647 News Found

USFDA inspection update on Jubilant HollisterStier’s Montreal facility
Drug Approval | September 30, 2024

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures


Fermenta Biotech receives EU GMP Certification for its Dahej facility
News | September 23, 2024

Fermenta Biotech receives EU GMP Certification for its Dahej facility

This approval reflects company’s unwavering commitment that the quality assurance


Laurus Labs inaugurates Rs. 250 crore R&D facility in Telangana
News | September 16, 2024

Laurus Labs inaugurates Rs. 250 crore R&D facility in Telangana

Total investment incurred for setting up the new R&D Rs 250 crore


USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations
Drug Approval | September 14, 2024

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices


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