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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Aurobindo Pharma arm Unit IV gets 5 USFDA observations

Lupin Pithampur Unit-1 facility gets EIR from USFDA

Ruchika Sharma9 Jan 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...
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

USFDA issues EIR for Caplin Steriles Gummidipoondi facility

Ruchika Sharma7 Jan 2025 11:30 AM IST
Chennai: Caplin Point Laboratories Ltd. has announced that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug...
Biocon Biologics Secures BB+ Rating Upgrade from S&P on Improved Financial Metrics

USFDA issues EIR for Biocon Bengaluru facility

Ruchika Sharma25 Dec 2024 12:53 PM IST
Bengaluru: Biocon has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and...
Natco Pharma gets 7 USFDA observations for Kothur Pharma Division

Aarti Drugs gets USFDA EIR for Tarapur facility

Ruchika Sharma24 Dec 2024 4:22 PM IST
Mumbai: Aarti Drugs Limited has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) at the end...
Granules India packaging facility in US successfully completes USFDA inspection

USFDA inspection: Aurobindo Pharma arm Telangana facility gets 2 observations

Ruchika Sharma18 Dec 2024 12:30 PM IST
Telangana: Aurobindo Pharma has announced in a BSE filing that the US Food and Drug Administration (USFDA) has concluded inspection with 2...
Indoco Remedies gets USFDA EIR for Patalganga facility

Indoco Remedies receives warning letter from USFDA for Goa facility

Ruchika Sharma17 Dec 2024 4:04 PM IST
Mumbai: Indoco Remedies has received a warning letter from the US Food and Drug Administration (USFDA) for the company's Plant II & Plant III...
Biocon Biologics Gets Health Canada Nod for Yesintek, a Biosimilar to Stelara

Biocon gets EIR with VAI status from USFDA for Bengaluru API facility

Ruchika Sharma9 Dec 2024 11:30 AM IST
Bangalore: In a recent BSE filing, Biocon has informed that the U.S. Food and Drug Administration (US FDA) has issued an Establishment...
USFDA Closes Inspection at Zydus Ankleshwar Unit-2 With Three Observations

Cipla gets 8 USFDA observations for Virgonagar facility

Ruchika Sharma14 Nov 2024 12:01 PM IST
Mumbai: Cipla has announced that the United States Food and Drugs Administration (USFDA) has concluded an inspection at the Company's...
Aurobindo Pharma arm Unit IV gets 5 USFDA observations

USFDA classifies Biocon Biologics Biocon Park Site in Bengaluru as VAI

Ruchika Sharma11 Nov 2024 11:33 AM IST
Bengaluru: Biocon has announced that the U.S. Food and Drug Administration (USFDA) has classified Biocon Biologics' facilities at Biocon Park,...
USFDA Closes Inspection at Zydus Ankleshwar Unit-2 With Three Observations

Granules India Unit V facility receives USFDA EIR with 'No Action Indicated' status

Ruchika Sharma8 Nov 2024 10:00 AM IST
Hyderabad: Granules India Limited, a pharmaceutical manufacturing company, has announced that it has received an Establishment Inspection Report (EIR)...
Shilpa Medicare bags initial authorization for Rotigotine Transdermal Patch from Europe

Shilpa Medicare gets four USFDA observations for Bengaluru facility

Ruchika Sharma4 Nov 2024 3:58 PM IST
Raichur: Shilpa Medicare has announced that the US Food and Drug Administration (USFDA) has issued Form 483 with four observations at the...
Ciplas Lanreotide Supply Partners Greece Plant Gets USFDA OAI Status

USFDA classifies Cipla Goa facility as VAI

Ruchika Sharma4 Nov 2024 11:30 AM IST
Mumbai: Through a recent BSE filing, Cipla has informed that the United States Food and Drug Administration (USFDA) has classified the routine...
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