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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Lupin receives USFDA observations for two Pithampur manufacturing Units

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...
USFDA issues 4 observations for Zydus Jarod injectable manufacturing plant

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...
Health Ministry Proposes Notification-Based Approval for Pharma Export BE Studies Instead of Central Licensing Authority Nod

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 SEZ II, Ahmedabad plant

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 Glucagon for Injection for severe hypoglycemia in patients with diabetes mellitus 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...
USFDA issues 4 observations for Zydus Jarod injectable manufacturing plant

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 Fails to Secure CDSCO Nod for BE, Phase III Waiver on Sitagliptin, Glimepiride, Metformin FDC

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 appoints Ekta Agarwal as Interim Company Secretary, Compliance Officer

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 Glucagon for Injection for severe hypoglycemia in patients with diabetes mellitus 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...
USFDA concludes inspection at Zydus Lifesciences SEZ II, Ahmedabad plant

Torrent Pharma gets 5 USFDA observations for Indrad facility

Ruchika Sharma13 Jun 2024 12:09 PM IST
Ahmedabad: Through a recent BSE filing, Torrent Pharma has informed that the US Food and Drug Administration (USFDA) has issued Form 483...
Unichem Labs Roha facility gets 3 USFDA observations

Dr Reddy's Labs gets 4 USFDA observations for Srikakulam facility

Ruchika Sharma8 Jun 2024 12:30 PM IST
Hyderabad: Through a recent BSE filing, Dr Reddy's Labs has informed that the United States Food & Drug Administration (USFDA) has completed...
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