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Results For "USFDA"

1126 News Found

Dr Reddy’s launch Venlafaxine ER tablets in the US
Drug Approval | December 10, 2021

Dr Reddy’s launch Venlafaxine ER tablets in the US

The tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.


Gland Pharma receives tentative approval for Cangrelor
Drug Approval | December 09, 2021

Gland Pharma receives tentative approval for Cangrelor

Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity


Dr Reddy’s launch valsartan tablets in the US market
Drug Approval | December 09, 2021

Dr Reddy’s launch valsartan tablets in the US market

Dr. Reddy's valsartan tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90


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


Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue
Biotech | December 07, 2021

Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue

The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects


Unichem Labs gets ANDA approval for schizophrenia medicine
Drug Approval | December 03, 2021

Unichem Labs gets ANDA approval for schizophrenia medicine

The product will be commercialized from Unichem's Ghaziabad plant


Medical devices industry needs reforms:  Mehernosh Daruwalla, Founder & MD, Lotus Surgicals
interviews | November 24, 2021

Medical devices industry needs reforms: Mehernosh Daruwalla, Founder & MD, Lotus Surgicals

The Indian medical devices industry has been in focus since the pandemic. From US $ 11 billion in 2020 it is expected to touch US $ 50 billion by 2025. Mehernosh Daruwalla, Founder and MD, Lotus Surgicals shares a perspective with Thomas C Thottathil on the opportunities in this sector


U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution
Drug Approval | November 23, 2021

U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution

The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies


Pfizer seeks EUA from U.S. FDA for Covid-19 drug
Biotech | November 17, 2021

Pfizer seeks EUA from U.S. FDA for Covid-19 drug

If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2


Alembic JV receives final approval for Mupirocin cream
Drug Approval | November 17, 2021

Alembic JV receives final approval for Mupirocin cream

The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA