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Tag: usfda

You Searched For "usfda"
Philips respiratory devices recall classified as most serious by USFDA

Philips respiratory devices recall classified as most serious by USFDA

Ruchika Sharma19 Feb 2023 11:30 AM IST
US: The U.S. Food and Drug Administration (FDA) has classified the recall of Dutch medical devices maker Philips' (PHG.AS) respiratory machines...
CDSCO nod to medical smartwatch CardiacSense

CDSCO nod to medical smartwatch CardiacSense

Ruchika Sharma18 Feb 2023 11:00 AM IST
"CardiacSense is one such device that will enable doctors and hospitals to monitor patients 24/7 who have recently undergone major surgeries or those...
Alembic Pharma Karkhadi facility gets EIR from USFDA

Alembic Pharma Karkhadi facility gets EIR from USFDA

Ruchika Sharma17 Feb 2023 1:00 PM IST
Vadodara: Alembic Pharma has announced that the Company has received an Establishment Inspection Report (EIR) from the US Food and Drug...
Senores Pharma arm facility gets 3 USFDA observations

Lupin gets USFDA EIR for Nagpur facility

Ruchika Sharma17 Feb 2023 11:36 AM IST
Mumbai: Global pharma major Lupin Limited today announced that the company has received the Establishment Inspection Report (EIR) from the United...
USFDA nod to Zydus Eluxadoline tablets for irritable bowel syndrome with diarrhoea

Zydus Lifesciences Sirolimus Tablets bags USFDA okay

Ruchika Sharma17 Feb 2023 10:00 AM IST
The drug will be manufactured at the group's formulation manufacturing facility at Moraiya.
USFDA nod to Zydus Lifesciences hypertension drug

USFDA nod to Zydus Lifesciences hypertension drug

Ruchika Sharma15 Feb 2023 3:51 PM IST
The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.
Zydus Lifesciences bags tentative USFDA nod for Canagliflozin Tablets

Zydus Lifesciences bags tentative USFDA nod for Canagliflozin Tablets

Ruchika Sharma15 Feb 2023 2:15 PM IST
The drug will be manufactured at the group's formulation manufacturing facility at Moraiya.
Aurobindo Pharma arm gets marketing authorisation in UK for Zefylti

Aurobindo Pharma Telangana facility gets VAI classification from USFDA

Ruchika Sharma15 Feb 2023 12:15 PM IST
New Delhi: Aurobindo Pharma has announced that the company has received Voluntary Action Indicated (VAI) from the US health regulator for its...
Caplin Steriles gets USFDA nod for Carboprost Tromethamine Injection

Caplin Steriles gets USFDA nod for Carboprost Tromethamine Injection

Ruchika Sharma14 Feb 2023 1:15 PM IST
Carboprost Tromethamine Injection USP is an oxytocic, indicated for the treatment of postpartum hemorrhage due to uterine atony.
Natco Pharma announces submission of ANDA with USFDA for generic version of Olaparib Tablets

Natco Pharma announces submission of ANDA with USFDA for generic version of Olaparib Tablets

Ruchika Sharma13 Feb 2023 12:25 PM IST
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer.
Biocon Biologics expands biosimilar insulin portfolio with USFDA nod of Kirsty

Biocon partner Viatris gets Complete Response Letter from USFDA for Bevacizumab license application

Ruchika Sharma13 Feb 2023 11:13 AM IST
Bevacizumab is a medication used to treat a number of types of cancers and a specific eye disease.
Regeneron Pharma gets USFDA nod for EYLEA Injection to treat preterm infants with retinopathy of prematurity

Regeneron Pharma gets USFDA nod for EYLEA Injection to treat preterm infants with retinopathy of prematurity

Ruchika Sharma12 Feb 2023 3:00 PM IST
EYLEA is a VEGF inhibitor formulated as an injection for the eye.
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