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  • usfda inspection

Tag: usfda inspection

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

USFDA issues EIR for Lupin Aurangabad facility

Ruchika Sharma24 April 2024 11:46 AM IST
Mumbai: Global pharma major Lupin Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States...
Carlyle to offload up to 10 percent stake in Piramal Pharma in Rs 26-27 billion deal: Report

USFDA successfully concludes inspection at Piramal Pharma USA facility

Ruchika Sharma18 April 2024 5:36 PM IST
Mumbai: Piramal Pharma Limited has informed through a recent BSE filing that the US Food and Drug ADministration (US FDA) has issued an...
Unichem Labs Roha facility gets 3 USFDA observations

Marksans Pharma gets 5 inspectional observations from USFDA for Goa facility

Ruchika Sharma18 April 2024 12:14 PM IST
Mumbai: Marksans Pharma has received 5 inspectional observations in Form 483 from the US Food and Drug Administration (USFDA) at...
Granules India enters high growing peptide segment, CDMO business by acquiring Senn Chemicals

Granules India gets Zero 483's from USFDA for Unit V facility in AP

Ruchika Sharma13 April 2024 12:08 PM IST
Telangana: Granules India has informed in a BSE filing that the Company's Unit V facility located at Anakapally, Visakhapatnam, Andhra ...
USFDA concludes inspection at Zydus Lifesciences SEZ II, Ahmedabad plant

USFDA concludes inspection of Lupin Dabhasa facility with no observations

Ruchika Sharma13 April 2024 11:48 AM IST
Mumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has completed a GMP...
Revise Phase III Trial Protocol for Roflumilast Cream: CDSCO Panel Tells Sun Pharma

Sun Pharma receives OAI status from USFDA for Dadra facility

Ruchika Sharma12 April 2024 11:42 AM IST
Mumbai: Sun Pharma has informed in a BSE filing that the US Food and Drug Administration (USFDA) has determined the inspection classification...
After Manipal Hospitals, PMC warns all private hospitals against withholding dead bodies over unpaid bills

Natco Pharma Kothur facility gets USFDA warning letter

Ruchika Sharma9 April 2024 2:27 PM IST
Hyderabad: Natco Pharma has received a Warning Letter from the United States Food and Drug Administration (USFDA) for its Pharma Division...
USFDA concludes inspection at Zydus Lifesciences SEZ II, Ahmedabad plant

Aurobindo Pharma arm gets 3 USFDA observations for AP injectable facility

Ruchika Sharma7 April 2024 1:00 PM IST
Hyderabad: In a recent BSE filing, Aurobindo Pharma has informed that the new injectable facility of Eugia Steriles Private Limited, a 100%...
Cipla Bommasandra facility gets VAI classification from USFDA

Cipla gets 6 USFDA observations for Maha facility

Ruchika Sharma5 April 2024 11:51 AM IST
Mumbai: Cipla has received six inspectional observations in Form 483 from the United States Food and Drug Administration (USFDA) at the...
USFDA issues 4 observations for Zydus Jarod injectable manufacturing plant

USFDA classifies Granules Pharma facility as Voluntary Action Indicated

Ruchika Sharma4 April 2024 3:00 PM IST
Hyderabad: Granules India has informed in a BSE filing that the United States Food and Drug Administration (USFDA) has classified the facility of...
Zydus, Synthon enters into licensing, supply agreement for multiple sclerosis drug Ozanimod for US

USFDA inspection: Zydus Lifesciences gets 4 observations for Ahmedabad plant

Ruchika Sharma28 March 2024 12:30 PM IST
Ahmedabad: Zydus Lifesciences has announced that the Company has received four observations from the U.S. Food and Drug Administration (USFDA) at...
USFDA issues 4 observations for Zydus Jarod injectable manufacturing plant

USFDA issues ten observations for Alkem Labs Baddi facility

Ruchika Sharma28 March 2024 11:29 AM IST
Mumbai: Alkem Labs has announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483 with ten observations at the...
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