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Results For "manufacturing-facility"

631 News Found

Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection
Drug Approval | December 30, 2024

Cenexi's Fontenay manufacturing facility receives 10 observations in ANSM inspection

Cenexi is committed to working closely with the ANSM to address the observations


Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ
Drug Approval | December 17, 2024

Rusan Pharma achieves GMP approvals from TGA (Australia) and ANVISA (Brazil) for its manufacturing facility in Kandla SEZ

The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market


Lonza announces first GMP batch completion at next-generation mammalian manufacturing facility in US
News | November 25, 2024

Lonza announces first GMP batch completion at next-generation mammalian manufacturing facility in US

First GMP batch released at Lonza’s next-generation mammalian manufacturing facility in Portsmouth (US)


Lubrizol and Polyhose ink MoU to set up medical tube manufacturing facility in Tamil Nadu
News | November 15, 2024

Lubrizol and Polyhose ink MoU to set up medical tube manufacturing facility in Tamil Nadu

This agreement reinforces Lubrizol’s commitment to Make-In-India and broadens a previously committed US$ 350 million investment to support local manufacturing


Zydus receives EIR for the transdermal manufacturing facility
Drug Approval | October 02, 2024

Zydus receives EIR for the transdermal manufacturing facility

This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated


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


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


Lupin receives EIR from US FDA for its Somerset manufacturing facility
Drug Approval | June 25, 2024

Lupin receives EIR from US FDA for its Somerset manufacturing facility

The facility was inspected from May 7 to May 17, 2024


USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit
Drug Approval | June 19, 2024

USFDA completes audit of contract manufacturing facility of Jubilant Pharmova Montreal unit

The USFDA has issued 15 observations pursuant to the completion of audit. JHSGP will submit an action plan on the observations