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Results For "Official-Action-Indicated"

22 News Found

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1
Drug Approval | September 24, 2025

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1

The facility has been classified as Voluntary Action Indicated


FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US
Drug Approval | September 10, 2025

FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US

Sun Pharma's Halol plant gets OAI classification from US FDA inspection


Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr
News | August 08, 2025

Hikal reports Q1 FY26 consolidated loss of Rs. 22.4 Cr

Hikal has reported total income of Rs. 381.4 crores during the period ended June 30, 2025


USFDA classifies Aurobindo Pharma Inc's warehouse as OAI
Drug Approval | February 21, 2025

USFDA classifies Aurobindo Pharma Inc's warehouse as OAI

The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated


Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3
Drug Approval | October 14, 2024

Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3

Indoco is comprehensively working on the remedial action plan


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


Briefs: Sun Pharma and Kimia Biosciences
News | April 14, 2024

Briefs: Sun Pharma and Kimia Biosciences

Sun Pharma's Dadra facility receives OAI status from US FDA


USFDA inspects contract manufacturing facility of Jubilant Pharmova at Montreal Canada
Drug Approval | June 01, 2023

USFDA inspects contract manufacturing facility of Jubilant Pharmova at Montreal Canada

The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.