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Results For "ANDA"

2085 News Found

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


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


Unichem Laboratories receives ANDA approval for Apremilast Tablets
News | February 20, 2021

Unichem Laboratories receives ANDA approval for Apremilast Tablets

Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis .


Glenmark receives ANDA approval for Clindamycin Phosphate Gel
News | February 12, 2021

Glenmark receives ANDA approval for Clindamycin Phosphate Gel

According to IQVIA sales data for the 12 month period ending December 2020, the Cleocin T Gel, 1% market achieved annual sales of approximately $73.8 million.


Lupin launches Eslicarbazepine Acetate tablets in US
Drug Approval | May 08, 2025

Lupin launches Eslicarbazepine Acetate tablets in US

Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity