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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Laurus Labs gets 1 USFDA observation for Visakhapatnam facility

Laurus Labs gets 1 USFDA observation for Visakhapatnam facility

Ruchika Sharma29 Oct 2022 3:32 PM IST
Hyderabad: Laurus Labs today announced that the US Food and Drug Administration (USFDA) has concluded a PreApproval Inspection (PAI) with...
Glenmark Baddi facility placed under import alert by USFDA

Glenmark Baddi facility placed under import alert by USFDA

Ruchika Sharma28 Oct 2022 11:28 AM IST
Glenmark said it will engage with the agency to resolve the import alert at the earliest.
Alembic Pharma gets four USFDA observations for Panelav facility

Alembic Pharma Vadodara facility concludes USFDA inspection with zero observations

Ruchika Sharma27 Oct 2022 1:30 PM IST
Vadodara: Alembic Pharma has recently announced that the Company has successfully completed the United States Food and Drug Administration...
Marksans Pharma arm New York facility gets 1 USFDA observation

Lupin gets 17 USFDA observations for Pune facility

Ruchika Sharma20 Oct 2022 11:20 AM IST
"The Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility," Lupin stated.
Alembic Pharma gets four USFDA observations for Panelav facility

Alembic Pharma Panelav facility gets 4 USFDA observations

Ruchika Sharma19 Oct 2022 12:00 PM IST
Vadodara: Drugmaker, Alembic Pharma, has recently announced that the United States Food and Drug Administration (USFDA) has issued a Form 483 with 4...
USFDA issues EIR for Suven Pharma arm Casper Parma

USFDA issues EIR for Suven Pharma arm Casper Parma

Ruchika Sharma4 Oct 2022 4:27 PM IST
The inspection concluded with no observation (FDA-483) issued.
Lupin gets USFDA EIR for Ankleshwar unit

Lupin gets USFDA EIR for Ankleshwar unit

Ruchika Sharma3 Oct 2022 11:28 AM IST
The inspection of the facility was conducted from August 16-19, 2022.
USFDA issues 2 observations for Zydus Lifesciences arm Ahmedabad facility

USFDA issues 2 observations for Zydus Lifesciences arm Ahmedabad facility

Ruchika Sharma1 Oct 2022 2:30 PM IST
Ahmedabad: Pharma major, Zydus Lifesciences, has recently announced that the US Food and Drug Administration (USFDA) has concluded a Pre-Approval...
USFDA inspection: Lupin gets warning letter for Tarapur facility

USFDA inspection: Lupin gets warning letter for Tarapur facility

Ruchika Sharma29 Sept 2022 2:30 PM IST
Mumbai: Pharma major, Lupin, has announced that the Company has received a warning letter from the US Food and Drug Administration (USFDA)...
Torrent Pharma gets 3 observations from USFDA for Gujarat facility

Torrent Pharma gets 3 observations from USFDA for Gujarat facility

Ruchika Sharma29 Sept 2022 1:15 PM IST
Ahmedabad: Drugmaker, Torrent Pharma, has recently announced that the US Food and Drug Administration (USFDA) has issued a "Form 483" with 3...
Cipla gets USFDA EIR for Indore facility

Cipla gets USFDA EIR for Indore facility

Ruchika Sharma24 Sept 2022 11:07 AM IST
Mumbai: Pharma major, Cipla, has recently announced that the Company has received Establishment Inspection Report (EIR) from the United States Food...
Aurobindo Pharma US arm gets USFDA EIR for Raleigh facility

Aurobindo Pharma US arm gets USFDA EIR for Raleigh facility

Ruchika Sharma23 Sept 2022 2:32 PM IST
Hyderabad: Aurobindo Pharma has recently announced that Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company has received an...
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