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Tag: usfda

You Searched For "usfda"
Zydus Lifesciences bags USFDA nod for hypotension injection Ephedrine Sulfate

Zydus Lifesciences bags USFDA nod for hypotension injection Ephedrine Sulfate

Ruchika Sharma17 May 2023 12:13 PM IST
The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara, India.
Lupin receives USFDA observations for two Pithampur manufacturing Units

Dr Reddy's Labs gets 4 USFDA observations for Srikakulam facility

Ruchika Sharma13 May 2023 2:16 PM IST
Hyderabad: Dr Reddy's Labs has announced that the United States Food & Drug Administration (USFDA) today completed a product-specific...
Caplin Steriles bags USFDA nod for Ketorolac Tromethamine Injection

Caplin Steriles bags USFDA nod for Ketorolac Tromethamine Injection

Ruchika Sharma12 May 2023 2:35 PM IST
Ketorolac Tromethamine Injection USP is a nonsteroidal anti-inflammatory drug (NSAID), indicated for the short-term management of moderately severe...
Zydus Lifesciences Moraiya facility gets EIR from USFDA

Zydus Lifesciences Moraiya facility gets EIR from USFDA

Ruchika Sharma11 May 2023 11:35 AM IST
The inspection was a PAI for Transdermal Patch products
AstraZeneca Farxiga approved in US to reduce risk of cardiovascular death, hospitalisation for heart failure to broader range of patients

AstraZeneca Farxiga approved in US to reduce risk of cardiovascular death, hospitalisation for heart failure to broader range of patients

Ruchika Sharma10 May 2023 12:30 PM IST
Cambridge: AstraZeneca has announced that Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death,...
Alembic Pharma commissions new manufacturing facility in Pithampur to expand business

Alembic Pharma gets USFDA EIR for Jarod facility

Ruchika Sharma10 May 2023 11:32 AM IST
Vadodara: Pharma major, Alembic Pharmaceuticals, has announced that the Company has received Establishment Inspection Report (EIR) from US Food...
No Waiver for Faricimab: CDSCO Panel Asks Roche to Conduct Phase III Trial in India

USFDA accepts application for Roche Vabysmo for retinal vein occlusion treatment

Ruchika Sharma9 May 2023 11:42 AM IST
Retinal vein occlusion is the second most common cause of vision loss due to retinal vascular diseases.
USFDA warning: Do not use certain SD Biosensor Pilot COVID-19 At-Home tests

USFDA warning: Do not use certain SD Biosensor Pilot COVID-19 At-Home tests

Ruchika Sharma8 May 2023 3:30 PM IST
USFDA said, "The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test...
Sun Pharma recalls pre-filled syringes of infertility drug in US over manufacturing issue

Sun Pharma recalls pre-filled syringes of infertility drug in US over manufacturing issue

Ruchika Sharma8 May 2023 11:31 AM IST
"A piece of glass was found in a prefilled syringe," USFDA said.
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

Dr Reddy's Labs unveils Regadenoson Injection in US

Ruchika Sharma6 May 2023 2:30 PM IST
Hyderabad: Drug major, Dr. Reddy's Laboratories Ltd. has announced the launch of Regadenoson Injection in the U.S. market, a generic therapeutic...
Senores Pharma arm facility gets 3 USFDA observations

Dr Reddys Labs gets one USFDA observation for Hyderabad facility

Ruchika Sharma6 May 2023 12:30 PM IST
Hyderabad: Pharma major, Dr Reddy's Labs, has recently announced that the United States Food & Drug Administration (USFDA) has issued a Form 483...
USFDA nod to Zydus Eluxadoline tablets for irritable bowel syndrome with diarrhoea

Zydus Lifesciences bags USFDA nod for ulcer drug Sucralfate

Ruchika Sharma5 May 2023 11:34 AM IST
Ahmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the company has received final approval from the United States Food and Drug...
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