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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Lupin bags tentative USFDA nod for Loteprednol Etabonate Ophthalmic Gel

Lupin Pithampur Unit-2 facility gets EIR from USFDA

Ruchika Sharma12 July 2023 11:15 AM IST
Mumbai: Global pharma major Lupin Limited has announced that the company has received the Establishment Inspection Report (EIR) from the United States...
Marksans Pharma arm New York facility gets 1 USFDA observation

Zydus Lifesciences concludes USFDA inspection at Ahmedabad facility with nil observations

Ruchika Sharma8 July 2023 10:32 AM IST
Ahmedabad: Pharma major, Zydus Lifesciences Ltd., has announced that the group’s manufacturing facility at SEZ-2 located at Pharmez, Ahmedabad,...
Marksans Pharma arm New York facility gets 1 USFDA observation

Granules India completes USFDA audit at Visakhapatnam facility with zero 483 observations

Ruchika Sharma3 July 2023 12:30 PM IST
Hyderabad: Granules India Limited, a vertically integrated pharmaceutical company, has completed the U.S. Food and Drug Administration’s (US FDA)...
Zydus Lifesciences gets EIR from USFDA for Pharmez facility

Zydus Lifesciences gets EIR from USFDA for Pharmez facility

Ruchika Sharma3 July 2023 11:44 AM IST
Ahmedabad: Zydus Lifesciences has recently announced thatthe Company has received the Establishment Inspection Report (EIR) from the United States...
Aurobindo Pharma arm CuraTeQ Biologics gets UK MHRA nod for cancer treatment Bevqolva

USFDA uncovers fresh faults at Aurobindo Pharma

MD Bureau1 July 2023 10:00 AM IST
US Food and Drug Administration officials found multiple faults at a plant run by one of India’s biggest drugmakers as the watchdog continues to...
Gland Pharma gets one USFDA observation for Pashamylaram Facility

Gland Pharma gets one USFDA observation for Pashamylaram Facility

Ruchika Sharma28 Jun 2023 11:15 AM IST
Hyderabad: Gland Pharma has recently announced that the US Food and Drug Administration (USFDA) has concluded the inspection at the...
Ajanta Pharma to add liquid formulation facility at Pithampur site

Ajanta Pharma Dahej facility concludes USFDA inspection with no Form 483

Ruchika Sharma26 Jun 2023 11:08 AM IST
Mumbai: Ajanta Pharma has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection at the Company's Dahej...
Aurobindo Pharma arm gets USFDA EIR for Telangana unit

USFDA successfully concludes inspection at Granules India Jeedimetla facility

Ruchika Sharma24 Jun 2023 12:30 PM IST
Hyderabad: Granules India has recently announced that Company’s Jeedimetla facility located at Hyderabad, Telangana, India has successfully completed...
USFDA issues EIR for Lupin Vizag facility

USFDA issues EIR for Lupin Vizag facility

Ruchika Sharma20 Jun 2023 11:26 AM IST
The inspection closed with the facility receiving an inspection classification of "No Action Indicated".
Torrent Pharma Receives USFDA Clearance for Pithampur Facility with VAI Classification

USFDA issues EIR for Torrent Pharma Bileshwarpura facility

Ruchika Sharma17 Jun 2023 4:17 PM IST
Ahmedabad: Torrent Pharma has recently announced that the US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR)...
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

USFDA inspection: Dr Reddy's Labs gets zero obervations for Bollaram facility, EIR for Srikakulam facility

Ruchika Sharma17 Jun 2023 12:10 PM IST
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has completed a GMP inspection at the...
Natco Pharma Vizag facility gets EIR from USFDA

Natco Pharma Vizag facility gets EIR from USFDA

Ruchika Sharma16 Jun 2023 1:30 PM IST
Hyderabad: Natco Pharma Limited has announced the successful closure of inspection and received Establishment Inspection Report (EIR) from the...
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