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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Aurobindo Pharma arm Telangana facility gets 5 USFDA observations

USFDA issues three observations each on API, Finished Product side of Lupin Pithampur facility

Ruchika Sharma28 Sept 2024 12:15 PM IST
Mumbai: Lupin has announced that the United States Food and Drug Administration (USFDA) has issued three observations each on the API and...
AbbVie seeks USFDA nod for combination regimen of Venclexta, Acalabrutinib

USFDA completes audit at Jubilant HollisterStier 2 Washington facilities

Ruchika Sharma26 Sept 2024 10:30 AM IST
Noida: Jubilant Pharmova Limited has announced that the United States Food and Drug Administration (USFDA) has concluded an audit of the Jubilant...
Biocon appoints Ekta Agarwal as Interim Company Secretary, Compliance Officer

USFDA concludes inspection at Biocon Bengaluru API facility

Ruchika Sharma23 Sept 2024 12:06 PM IST
Bangalore: Biocon has announced that the U.S. Food and Drug Administration (US FDA) has concluded a surveillance inspection at the Company's...
Unichem Labs Roha facility gets 3 USFDA observations

Aarti Drugs gets 7 inspectional USFDA observations for Tarapur facility

Ruchika Sharma23 Sept 2024 11:00 AM IST
Maharashtra: Aarti Drugs Limited has announced that the United States Food and Drug Administration (US FDA) has issued 7 inspectional...
USFDA concludes inspection at Zydus Lifesciences SEZ II, Ahmedabad plant

USFDA completes inspection at Dr Reddy's Labs Bachupally RnD centre

Ruchika Sharma21 Sept 2024 11:35 AM IST
Hyderabad: In a recent BSE filing, Dr Reddy's Labs has informed that the United States Food & Drug Administration (USFDA) has completed...
Aurobindo Pharma arm Telangana facility gets 5 USFDA observations

Torrent Pharma gets one USFDA observation for Pithampur facility

Ruchika Sharma19 Sept 2024 5:30 PM IST
Ahmedabad: Torrent Pharma has announced that the United States Food & Drug Administration (USFDA) has issued one observation at the end...
Aurobindo Pharma in lead to acquire Zentiva for US 5.5 billion: ET Report

Aurobindo Pharma arm AP facility gets EIR from USFDA

Ruchika Sharma18 Sept 2024 11:30 AM IST
Hyderabad: Aurobindo Pharma has announced that the new injectable facility of Eugia Steriles Private Limited (a 100 percent subsidiary of...
Regulatory Roadblock for Zydus: CDSCO Panel Halts MMRV Vaccine Trial, Seeks Adult Data

Zydus Lifesciences pulled up by USFDA for manufacturing lapses at Gujarat plant

Ruchika Sharma17 Sept 2024 12:33 PM IST
New Delhi: Zydus Lifesciences has been pulled up by the US health regulator for manufacturing lapses at its Gujarat-based plant.In a warning letter to...
AbbVie seeks USFDA nod for combination regimen of Venclexta, Acalabrutinib

Laurus Labs Hyderabad facility successfully completes USFDA audit

Ruchika Sharma16 Sept 2024 11:30 AM IST
Hyderabad: Laurus Labs Ltd., a research and development driven pharmaceutical and biotech company in India has announced the successful completion of...
Aurobindo Pharma arm Telangana facility gets 5 USFDA observations

Aurobindo Pharma step-down arm AP facility gets product approval from USFDA

Ruchika Sharma12 Sept 2024 11:40 AM IST
Telangana: Aurobindo Pharma has announced that the new injectable facility of Eugia Steriles Private Limited , a 100% subsidiary of Eugia Pharma...
Unichem Labs Roha facility gets 3 USFDA observations

Unichem Labs Goa facility gets VAI status from USFDA

Ruchika Sharma11 Sept 2024 11:15 AM IST
Mumbai: Unichem Labs has announced that the US Food and Drug Administration (USFDA) has classified the inspection of Company’s Goa...
Aurobindo Pharma arm Telangana facility gets 5 USFDA observations

USFDA classifies Jubilant HollisterStier Spokane facility as VAI

Ruchika Sharma10 Sept 2024 5:00 PM IST
Noida: Jubilant Pharmova Limited has announced that Jubilant HollisterStier LLC (JHS) has received a communication from the USFDA, through which...
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