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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Zydus Lifesciences gets 2 USFDA observations for Ahmedabad site

Biocon gets 1 USFDA observation for Cranbury site

Ruchika Sharma13 Oct 2025 11:00 AM IST
Bangalore: Biocon has announced that its manufacturing site in Cranbury, New Jersey, has received a single observation following a GMP inspection...
Lupin unveils Liraglutide Injection in US for diabetes

Lupin gets 1 USFDA observation for Somerset facility

Ruchika Sharma12 Oct 2025 2:45 PM IST
Mumbai: Lupin has announced that the company has received one observation from the U.S. Food and Drug Administration (USFDA) after a Pre-Approval...
USFDA concludes inspection at Emcure Pharma Gujarat facility without any observation

USFDA concludes inspection at Emcure Pharma Gujarat facility without any observation

Ruchika Sharma11 Oct 2025 11:04 AM IST
Pune: Emcure Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection at...
USFDA approves Marksans Pharma anti-diarrheal medication

Lupin gets USFDA OAI status for Pithampur Unit 2 facility

Ruchika Sharma5 Oct 2025 11:00 AM IST
Mumbai: Lupin has announced that the U.S. Food and Drug Administration (USFDA) has issued Official Action Indicated (OAI) status for the...
USFDA approves Marksans Pharma anti-diarrheal medication

Jubilant Pharma arm completes USFDA inspection with zero observations

Ruchika Sharma22 Sept 2025 11:01 AM IST
Noida: Jubilant Pharmova Limited has announced the completion of the United States Food and Drug Administration (USFDA) Post-marketing Adverse Drug...
AP Drug Control Launches Mega GMP Inspection Across 400 Pharma Firms

Zydus gets USFDA EIR for Ahmedabad oncology injectable manufacturing facility

Ruchika Sharma22 Sept 2025 10:51 AM IST
Ahmedabad: Zydus has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for a GMP follow-up...
Lupin secures S&P Global ESG Score of 91 for 2025

Lupin gets 4 USFDA observations for Pune Biotech facility

Ruchika Sharma20 Sept 2025 2:45 PM IST
Mumbai: Lupin has announced that the company has received four observations from the U.S. Food and Drug Administration (USFDA) after an inspection at...
Indoco Remedies gets USFDA nod for venous thromboembolism drug Rivaroxaban

USFDA successfully completes inspection at Indoco Remedies Mumbai API facility

Ruchika Sharma19 Sept 2025 3:58 PM IST
Mumbai: Indoco Remedies Limited has announced that the United States Food and Drug Administration (USFDA) successfully completed inspection of...
Lupin gets seven USFDA observations for Goa facility

Natco Pharma gets USFDA EIR for Kothur Pharma division

Ruchika Sharma18 Sept 2025 12:52 PM IST
Hyderabad: Natco Pharma has announced that the U.S. Food and Drug Administration (USFDA) has issued Establishment Inspection Report (EIR) for the...
Lupin gets EIR from USFDA for Aurangabad Facility

Lupin gets 6 USFDA observations for Nagpur facility

Ruchika Sharma17 Sept 2025 11:00 AM IST
Mumbai: Lupin has announced that the U.S. Food and Drugs Administration (USFDA) has closed the inspection with six observations at the company's...
Cybercriminals Trick Dr Reddys Finance Team, Divert Rs 2.16 Crore Payment

Dr Reddys Labs gets 5 observations from USFDA for Bachupally facility

Ruchika Sharma13 Sept 2025 1:14 PM IST
Hyderabad: Dr Reddy's Laboratories has received five observations from the United States Food & Drug Administration (USFDA), after a...
Lupin gets seven USFDA observations for Goa facility

USFDA concludes audit at Cohance Lifesciences Jaggaiahpet facility

Ruchika Sharma13 Sept 2025 12:37 PM IST
Hyderabad: Cohance Lifesciences has announced that the United States Food and Drug Administration (USFDA) has completed a general current Good...
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