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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Not a Nice Time For Dr Reddys? DTAB, CDSCO Recommends Stringent Restrictions on Nimesulide

USFDA issues EIR for Dr Reddy's Labs Hyderabad facility

Ruchika Sharma26 Feb 2025 2:30 PM IST
Hyderabad: Dr Reddy's Labs has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food...
Gland Pharma ropes in Wriddhee Maitra as Vice-President (Human Resources)

Gland Pharma gets 3 USFDA observations for Visakhapatnam facility

Ruchika Sharma26 Feb 2025 11:30 AM IST
Hyderabad: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection with three observations...
Syngene buys its first manufacturing facility in US

Syngene International gets 5 USFDA observations for Bengaluru facilities

Ruchika Sharma24 Feb 2025 11:30 AM IST
Bengaluru: Syngene International has announced that the U.S. Food and Drugs Administration (USFDA) has concluded the inspection with five...
Lupin gets green light from USFDA for kidney drug Tolvaptan

USFDA issues EIR for Lupin Somerset facility

Ruchika Sharma22 Feb 2025 11:30 AM IST
Mumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has issued the...
USFDA issues 2 observattions for Cipla arm Mahape facility

USFDA issues 2 observations for Cipla arm Mahape facility

Ruchika Sharma21 Feb 2025 1:30 PM IST
Mumbai: Cipla, an Indian multinational pharmaceutical company, has announced that the United States Food and Drugs Administration...
Novo Nordisk application for oral Wegovy accepted by USFDA for weight loss

USFDA issues 7 minor observations for Orchid Pharma Alathur facility

Ruchika Sharma20 Feb 2025 2:30 PM IST
New Delhi: Orchid Pharma Ltd., a vertically integrated pharmaceutical company, has received seven minor observations from the U.S. Food and...
Jubilant Pharmova arm Salisbury facility gets USFDA EIR

Aurobindo Pharma USA New Jersey warehouse gets USFDA OAI status

Ruchika Sharma20 Feb 2025 10:23 AM IST
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) had conducted an inspection at one of the ...
USFDA concludes inspection at Zydus Lifesciences Ankleshwar facility

USFDA issues 6 observations for Piramal Pharma Turbhe facility

Ruchika Sharma19 Feb 2025 12:30 PM IST
Mumbai: Piramal Pharma has announced that the Company has received six observations from US Food and Drug Administration (USFDA) at the...
Aurobindo Pharma arm gets European Commission authorization to market Dyrupeg in EU

Aurobindo Pharma arm Eugia Steriles gets 5 UFSDA observations

Ruchika Sharma19 Feb 2025 11:30 AM IST
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded a pre-approval...
Gadwal Hospital Inspection

USFDA concludes inspection at Zydus Lifesciences Ahmedabad site with zero observations

Ruchika Sharma18 Feb 2025 2:30 PM IST
Ahmedabad: Zydus Lifesciences has informed in a BSE filing that the US Food and Drug Administration (USFDA) has concluded a routine surveillance...
Alembic Pharma arm incorporates wholly-owned subsidiary in USA

Alembic Pharma gets USFDA EIR for Jarod facility

Ruchika Sharma18 Feb 2025 12:30 PM IST
Vadodara: Alembic Pharma has announced that the Company has received an Establishment Inspection Report (EIR) with classification as...
Gadwal Hospital Inspection

Zydus' Ambernath API Plant Clears USFDA Inspection with Zero Observations

Farhat Nasim15 Feb 2025 4:42 PM IST
Ahmedabad: Zydus Lifesciences Limited has announced the successful completion of a USFDA surveillance inspection at its Active Pharmaceutical...
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