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Results For "US-FDA"

251 News Found

Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq
Drug Approval | January 28, 2022

Granules receives ANDA approval for potassium chloride for oral solution USP, 20 mEq

Potassium chloride is used to prevent or to treat low blood levels of potassium


Emcure to launch oral Covid-19 drug soon
Drug Approval | January 03, 2022

Emcure to launch oral Covid-19 drug soon

A toll-free helpline to be set up to help doctors and patients


Granules receives ANDA approval for amphetamine mixed salts
Drug Approval | December 30, 2021

Granules receives ANDA approval for amphetamine mixed salts

The current annual U.S. market for amphetamine mixed salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg immediate release tablets strengths is approximately US $ 335 million, according to MAT, Oct 2021 IQVIA/IMS Health


Siemens Healthineers receive EUA for Covid-19 antigen self-test
Medical Device | December 30, 2021

Siemens Healthineers receive EUA for Covid-19 antigen self-test

Rapid antigen testing provides results in just 15 minutes and the information can help reduce the risk of Covid-19 exposure


Granules Inc., receives ANDA approval for prazosin hydrochloride
Drug Approval | December 28, 2021

Granules Inc., receives ANDA approval for prazosin hydrochloride

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health


Cipla receives final approval for Lanreotide injection
Drug Approval | December 20, 2021

Cipla receives final approval for Lanreotide injection

It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours


Healthium Medtech opens manufacturing facility in Gujarat
News | December 09, 2021

Healthium Medtech opens manufacturing facility in Gujarat

The Uteshiya facility, licensed by Healthium, will exclusively manufacture Healthium’s arthroscopy portfolio, including patented products in India and U.S.


Healthium Medtech Sri City facility in AP gets U.S. FDA registration
News | December 08, 2021

Healthium Medtech Sri City facility in AP gets U.S. FDA registration

This is the fourth facility from the company to receive this registration


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


Sluggish exports to cap pharma revenue growth at 9% this fiscal
News | November 17, 2021

Sluggish exports to cap pharma revenue growth at 9% this fiscal

A CRISIL study of 207 pharmaceutical companies that account for 55% of the Rs 3.2 lakh crore-a-year sector revenue indicates as much.