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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
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...
Granules India packaging facility in US successfully completes USFDA inspection

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 and TB Alliance Join Forces to Advance Telacebec

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 Closes Inspection at Zydus Ankleshwar Unit-2 With Three Observations

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 Names Sana Shaikh as Head of Marketing

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 BB+ Rating Upgrade from S&P on Improved Financial Metrics

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 and TB Alliance Join Forces to Advance Telacebec

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...
Granules India packaging facility in US successfully completes USFDA inspection

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...
Aurobindo Pharma arm Unit IV gets 5 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...
Aurobindo Pharma arm Unit IV gets 5 USFDA observations

Aurobindo Pharma arm Unit III facility gets USFDA OAI status

Ruchika Sharma25 May 2024 12:32 PM IST
Hyderabad: Through a recent BSE filing, Aurobindo Pharma has informed that the United States Food and Drug Administration (US FDA) has determined...
USFDA Closes Inspection at Zydus Ankleshwar Unit-2 With Three Observations

USFDA completes inspection at Gland Pharma Visakhapatnam facility with Zero 483 observations

Ruchika Sharma24 May 2024 4:33 PM IST
Telangana: Gland Pharma has informed in a BSE filing that the United States Food and Drug Administration (US FDA) has completed an...
Piramal Pharma gets 4 USFDA observations for Lexington facility

Piramal Pharma Lexington facility successfully completes USFDA Inspection

Ruchika Sharma23 May 2024 3:28 PM IST
Mumbai: Piramal Pharma Limited has informed in a recent BSE filing that the US Food and Drug Administration (US FDA) has issued an Establishment...
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