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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
USFDA concludes inspection at Zydus Lifesciences Ankleshwar facility

Jubilant Ingrevia receives USFDA EIR for Baruch facility

Ruchika Sharma28 Jun 2024 12:30 PM IST
Noida: Jubilant Ingrevia Limited has announced successful outcome of the USFDA inspection with the receipt of Establishment Inspection report...
Aurobindo Pharma arm gets marketing authorisation for Zefylti in EU

Aurobindo Pharma arm Telangana injectable unit gets USFDA VAI classification

Ruchika Sharma27 Jun 2024 3:03 PM IST
Telangana: Aurobindo Pharma has informed in a BSE filing that the injectable facility of Eugia SEZ Pvt. Ltd., a 100 per cent step-down subsidiary...
Marksans Pharma arm New York facility gets 1 USFDA observation

USFDA concludes inspection at Shilpa Medicare Hyderabad unit with zero observations

Ruchika Sharma26 Jun 2024 1:30 PM IST
Karnataka: Shilpa Medicare has announced that the US Food and Drug Administration (USFDA) has concluded the inspection at the Company's Bio...
Cipla arm Medispray Goa facility classified as VAI by USFDA

Cipla Patalganga facility gets VAI classification from USFDA

Ruchika Sharma26 Jun 2024 12:30 PM IST
Mumbai: Through a recent BSE filing, Cipla has informed that the United States Food and Drug Administration (USFDA) has classified the routine...
Unichem Labs Pithampur facility gets USFDA EIR

USFDA issues EIR for Alkem Labs Baddi facility

Ruchika Sharma25 Jun 2024 4:48 PM IST
Mumbai: Alkem Labs has informed in a BSE filing that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report...
Biocon gets USFDA nod for cancer drugs

American lawmakers question FDAs drug inspection programme in India, China

Ruchika Sharma25 Jun 2024 12:30 PM IST
Washington: Three prominent American lawmakers have questioned the Food and Drug Administration's foreign drug inspection program in India and...
USFDA concludes inspection at Zydus Lifesciences Ankleshwar facility

USFDA inspection: Biocon gets 4 observations for Visakhapatnam API facility

Ruchika Sharma24 Jun 2024 2:15 PM IST
Bangalore: Biocon has informed in a BSE filing that the U.S. Food and Drug Administration (USFDA) has concluded a GMP inspection of the...
Lupin unveils pregnancy prevention drug Minzoya in US

USFDA issues EIR for Lupin Somerset facility

Ruchika Sharma24 Jun 2024 11:18 AM IST
Mumbai: Global pharma major Lupin Limited today announced that it has received the Establishment Inspection Report (EIR) from the United States...
Unichem Labs Pithampur facility gets USFDA EIR

Cipla Goa facility gets 6 USFDA observations

Ruchika Sharma22 Jun 2024 3:31 PM IST
Mumbai: Pharma major, Cipla, has received six inspectional observations in Form 483 from the US Food and Drug Administration (USFDA) after...
Sun Pharma, Moebius Medical symptomatic knee osteoarthritis treatment MM-II

USFDA issues warning letter to Sun Pharma Dadra facility

Ruchika Sharma20 Jun 2024 12:34 PM IST
Mumbai: Sun Pharmaceutical Industries Limited has received a Warning Letter from the US Food and Drug Administration (USFDA) for its Dadra...
Biocon Biologics secures market entry date for Yesafili in US

USFDA issues 3 observations for Biocon Visakhapatnam API facility

Ruchika Sharma16 Jun 2024 11:00 AM IST
Bangalore: Biocon has informed in a BSE filing that the U.S. Food and Drug Administration (USFDA) has concluded...
Lupin unveils pregnancy prevention drug Minzoya in US

Lupin Nagpur Injectable facility concludes USFDA inspection with zero 483 observations

Ruchika Sharma14 Jun 2024 12:33 PM IST
Mumbai: Global pharma major Lupin Limited today announced that the United States Food and Drug Administration (U.S. FDA) has completed an...
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