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...
Shilpa Medicare Hyderabad division gets USFDA clearance Ruchika Sharma23 Sept 2022 12:15 PM ISTThe USFDA clearance on the facility will enable the company to test and release batches into the US from this facility.
Indoco Remedies AnaCipher CRO clears USFDA inspection with Zero observation Ruchika Sharma19 Sept 2022 2:47 PM ISTMumbai: Indoco Remedies Ltd. announced today that its Clinical Research Organisation, AnaCipher, located in Hyderabad, was inspected by the United...
USFDA issues 2 observations for Alkem Labs St Louis facility Ruchika Sharma17 Sept 2022 10:30 AM ISTMaharashtra: Alkem Labs has recently announced that the US Food and Drug Administration (USFDA) has issued two observations after a pre-approval...
Ajanta Pharma Dahej facility gets 2 procedural observations from USFDA Ruchika Sharma13 Sept 2022 12:15 PM ISTThe formulation facility was inspected by USFDA from 5th September 2022 to 9th September 2022.
Panacea Biotec arm gets USFDA OAI status for Baddi facility Ruchika Sharma8 Sept 2022 4:52 PM IST"PBPL is working closely with USFDA to close these observations and the closure of the warning letter issued by the USFDA earlier on September 24,...
