Last Updated on October 10, 2024 by The Health Master
Mumbai: The United States Food and Drug Administration (USFDA) has placed Sun Pharmaceuticals‘ Halol unit under “import alert.”
This means that all future shipments of products manufactured at this facility will be denied entry into the US market until the facility meets cGMP standards.
The USFDA inspected Sun Pharma’s Halol unit from April 26 to May 9, 2022. The USFDA has excluded 14 products from this import alert, subject to certain conditions.
The company said that supplies to the US market from the Halol facility accounted for roughly 3 percent of its consolidated revenue for the year ended March 31, 2022, including the 14 excluded products mentioned above.
“The Company continues to cooperate with the USFDA and will undertake all necessary steps to resolve these issues and ensure that the regulator is completely satisfied with the Company’s remedial action,” the company said in a statement to the exchanges.
Sun Pharma’s stock dipped following the disclosure. As of 10:20 am, the scrip was trading with a loss of 2.37 percent, while the broader index was trading up 0.24 percent.
Govt soon to set up Export Promotion Council for Medical Devices
CDSCO Panel gives nod for FDC Tamsulosin + Solifenacin
IPC alert: About Norfloxacin induced skin hyperpigmentation
NPPA releases 4th list of draft ceiling prices for 15 formulations
J&J baby powder sample fails quality test: FDA latest lab report
NPPA releases 3rd list with draft ceiling prices for 43 formulations
Drug recall: Sodium Bicarbonate Injection recalled due to this reason
USFDA-Gujarat FDCA to meet to discuss GMP compliance, capacity building
CDSCO panel gives nod for Esomeprazole Dual Release Gastro resistant tablets
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: