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  • usfda inspection

Tag: usfda inspection

You Searched For "usfda inspection"
Aurobindo Pharma arm CuraTeQ Biologics completes successful Phase 1 Pharmacokinetics study of bone drug

USFDA concludes inspection at Aurobindo Pharma Telangana facility with zero observations

Ruchika Sharma5 Aug 2023 11:49 AM IST
Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded the Pre-Approval Inspection (PAI)...
Aurobindo Pharma arm gets USFDA EIR for Telangana unit

Granules Pharma successfully completes USFDA inspection with zero observations

Ruchika Sharma4 Aug 2023 11:45 AM IST
Hyderabad: Granules India Limited, announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company, located in...
USFDA concludes inspection at Gland Pharma Visakhapatnam facility with zero 483 observations

USFDA concludes inspection at Gland Pharma Visakhapatnam facility with zero 483 observations

Ruchika Sharma31 July 2023 11:27 AM IST
Telangana: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has conducted Good Manufacturing Practice...
Lupin, Avas launch myotonia treatment NaMuscla in Italy

Lupin announces resolution of USFDA warning letter for Goa, Pithampur facilities

Ruchika Sharma28 July 2023 12:08 PM IST
Mumbai: Global pharma major Lupin Limited has announced that it has received correspondence from the US FDA that it has now addressed the concerns...
Aurobindo Pharma arm gets USFDA EIR for Telangana unit

Aurobindo Pharma arm Telangana facility concludes USFDA inspection with zero observations

Ruchika Sharma26 July 2023 2:38 PM IST
Hyderabad: Aurobindo Pharma has recently announced that the United States Food and Drug Administration (USFDA) has closed the inspection with zero...
Aurobindo Pharma arm gets USFDA EIR for Telangana unit

Aurobindo Pharma gets 3 USFDA observations for Telangana facility

Ruchika Sharma22 July 2023 1:35 PM IST
Telangana: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has issued ‘Form 483’ with 3...
Biocon Biologics to present at the 43rd Annual JP Morgan Healthcare Conference

USFDA inspection: Biocon Biologics gets 8 observations for Malaysia insulin facility

Ruchika Sharma22 July 2023 12:49 PM IST
Bengaluru: Biocon Biologics has announced that the U.S. Food and Drug Administration (FDA) conducted two cGMP inspections at Biocon Sdn. Bhd’s...
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

USFDA concludes inspection at Dr Reddy's Labs Srikakulam facility with zero observations

Ruchika Sharma20 July 2023 11:30 AM IST
The inspection closed with zero observations and a classification of No Action Indicated.
Aurobindo Pharma arm CuraTeQ Biologics gets positive opinion for biosimilar Dazublys from EMA

Aurobindo Pharma gets USFDA EIR for Anakapalli facility

Ruchika Sharma17 July 2023 11:29 AM IST
Hyderabad: Aurobindo Pharma has recently announced that the company has received Establishment Inspection Report from the U.S. Food and Drug...
Gland Pharma gets one 483 Observation from USFDA for Dundigal facility

Gland Pharma gets one 483 Observation from USFDA for Dundigal facility

Ruchika Sharma14 July 2023 1:29 PM IST
Hyderabad: Gland Pharma today announced that the United States Food and Drug Administration (USFDA) has issued one 483 Observation...
Aurobindo Pharma arm gets USFDA EIR for Telangana unit

USFDA issues EIR for Granules India Gagillapur facility

Ruchika Sharma14 July 2023 12:15 PM IST
Telangana: Indian pharmaceutical company, Graules India Limited, has announced that the US Food and Drug Administration (US FDA) has issued...
USFDA nod to Ipratropium Bromide Nasal Solution

USFDA issues two observations for Lupin Nagpur facility

Ruchika Sharma13 July 2023 1:04 PM IST
Mumbai: Lupin has announced the United States Food and Drug Administration (USFDA) has concluded the inspection at the...
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