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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

Granules India arm gets 5 USFDA observations for Hyderabad facility

Ruchika Sharma20 Dec 2025 12:38 PM IST
Telangana: Granules India has announced that the U.S. Food and Drug Administration (FDA) has concluded an inspection with five observations...
Biocon Told to Submit Detailed Toxicity, SAE Data on Semaglutide Prefilled Pen After Animal Deaths

USFDA issues EIR for Biocon Generics Cranbury facility

Ruchika Sharma19 Dec 2025 11:30 AM IST
Bengaluru: Biocon has announced that the Company has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated...
Sun Pharma Asked to Resubmit Revised Phase III Protocol for Delafloxacin CABP Trial

Sun Pharma Baska facility gets OAI status from USFDA

Ruchika Sharma18 Dec 2025 2:27 PM IST
Mumbai: Sun Pharma has announced that the company has received Official Action Indicated (OAI) status from the U.S. Food and Drug Administration...
Aurobindo Pharma arm Unit IV gets 5 USFDA observations

Aurobindo Pharma arm Unit IV gets 5 USFDA observations

Ruchika Sharma18 Dec 2025 11:30 AM IST
Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued five observations at the end of...
Granules India packaging facility in US successfully completes USFDA inspection

Lupin Nagpur injectable facility gets EIR from USFDA

Ruchika Sharma17 Dec 2025 11:30 AM IST
Mumbai: Global pharma major Lupin Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States...
Aurobindo Pharma arm API facility gets 3 observations from USFDA

Aurobindo Pharma arm API facility receives 3 observations from USFDA

Ruchika Sharma13 Dec 2025 12:58 PM IST
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) concluded the inspection with three...
Dr Reddys Labs secures European Commission approval for biosimilar to treat osteoporosis

Dr Reddy's Labs gets 5 USFDA observations for Srikakulam facility

Ruchika Sharma13 Dec 2025 12:17 PM IST
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) has completed a GMP and a...
Lupin gets seven USFDA observations for Goa facility

Granules Life Sciences facility receives EIR from USFDA

Ruchika Sharma13 Dec 2025 10:30 AM IST
Hyderabad: Granules India has announced that Granules Life Sciences Private Limited, a wholly owned subsidiary of the company situated in...
Piramal Pharma gets 4 USFDA observations for Lexington facility

USFDA inspection: Piramal Pharma receives 4 observations for Lexington facility

Ruchika Sharma12 Dec 2025 11:43 AM IST
Mumbai: Piramal Pharma has announced that the company has received four observations from the U.S. Food and Drug Administration (USFDA) for...
Indoco Remedies gets USFDA EIR for Patalganga facility

Indoco Remedies gets USFDA EIR for Patalganga facility

Ruchika Sharma12 Dec 2025 11:05 AM IST
Mumbai: Indoco Remedies Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and...
Himachal cracks down on pharma units, action taken against four facilities

Alkem Labs Daman facility gets 3 major, few minor observations from Malta Medicines Authority

Ruchika Sharma10 Dec 2025 11:25 AM IST
Mumbai: Alkem Labs has announced that the Malta Medicines Authority has concluded an inspection with three major observations and a few minor...
Ipca Pharma incorporates new wholly owned arm in Federal Republic of Germany

Ipca Labs receives 3 USFDA observations for Tarapur facility

Ruchika Sharma5 Dec 2025 3:06 PM IST
Mumbai: Ipca Labs has announced that the U.S. Food and Drug Administration (USFDA) has concluded inspection with three observations at the Company’s...
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