Laurus Labs gets 1 USFDA observation for Visakhapatnam facility Ruchika Sharma29 Oct 2022 3:32 PM ISTHyderabad: 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 Ruchika Sharma28 Oct 2022 11:28 AM ISTGlenmark said it will engage with the agency to resolve the import alert at the earliest.
Alembic Pharma Vadodara facility concludes USFDA inspection with zero observations Ruchika Sharma27 Oct 2022 1:30 PM ISTVadodara: Alembic Pharma has recently announced that the Company has successfully completed the United States Food and Drug Administration...
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 Panelav facility gets 4 USFDA observations Ruchika Sharma19 Oct 2022 12:00 PM ISTVadodara: 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 Ruchika Sharma4 Oct 2022 4:27 PM ISTThe inspection concluded with no observation (FDA-483) issued.
Lupin gets USFDA EIR for Ankleshwar unit Ruchika Sharma3 Oct 2022 11:28 AM ISTThe inspection of the facility was conducted from August 16-19, 2022.
USFDA issues 2 observations for Zydus Lifesciences arm Ahmedabad facility Ruchika Sharma1 Oct 2022 2:30 PM ISTAhmedabad: 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 Ruchika Sharma29 Sept 2022 2:30 PM ISTMumbai: 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 Ruchika Sharma29 Sept 2022 1:15 PM ISTAhmedabad: 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 Ruchika Sharma24 Sept 2022 11:07 AM ISTMumbai: 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 Ruchika Sharma23 Sept 2022 2:32 PM ISTHyderabad: Aurobindo Pharma has recently announced that Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company has received an...
