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Results For "NDA"

3729 News Found

Ajanta Pharma aims to file 10-12 ANDAs per annum
News | August 02, 2021

Ajanta Pharma aims to file 10-12 ANDAs per annum

India business is growing as per projections; whereas US business will bounce back soon.


Unichem receives tentative approval for ANDA of Sitagliptin tablets
News | July 11, 2021

Unichem receives tentative approval for ANDA of Sitagliptin tablets

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus


Glenmark receives ANDA tentative approval for Nintedanib Capsules
News | June 26, 2021

Glenmark receives ANDA tentative approval for Nintedanib Capsules

According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion


Glenmark receives ANDA approval for inhalation solution
News | June 24, 2021

Glenmark receives ANDA approval for inhalation solution

Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials will be manufactured in the company’s North American manufacturing facility based in Monroe, North Carolina


Glenmark receives ANDA approval for theophylline extended-release tablets
News | June 07, 2021

Glenmark receives ANDA approval for theophylline extended-release tablets

Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets


Glenmark receives ANDA approval for Icatibant Injection
News | May 25, 2021

Glenmark receives ANDA approval for Icatibant Injection

This marks Glenmark's first synthetic decapeptide injectable approval


Dr. Reddy's launches Albendazole tablets in US
News | April 30, 2021

Dr. Reddy's launches Albendazole tablets in US

Dr. Reddy’s Albendazole Tablets, USP are available in 200 mg tablets in bottle count sizes of two


NATCO receives approval for Ibrutinib tablets from ANDA
News | April 11, 2021

NATCO receives approval for Ibrutinib tablets from ANDA

The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths


Pharma sector has both brainpower and manpower to drive growth: Mandaviya
Policy | April 09, 2021

Pharma sector has both brainpower and manpower to drive growth: Mandaviya

The government has taken all the effective measures to make healthcare affordable


USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis
News | February 24, 2021

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis

The company will review FDA's response and decide on appropriate next steps soon.