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Results For "Glenmark-Pharmaceuticals"

84 News Found

Glenmark Pharmaceuticals USA reaches antitrust settlement with DOJ
News | August 24, 2023

Glenmark Pharmaceuticals USA reaches antitrust settlement with DOJ

The company has entered into a three-year Deferred Prosecution Agreement


Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%
Drug Approval | August 17, 2023

Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%

Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace


Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP
Drug Approval | March 15, 2023

Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP

Cleocin Hydrochloride Capsules market achieved annual sales of approximately US $33.6 million


Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg
Drug Approval | February 18, 2023

Glenmark Pharmaceuticals receives 2nd ANDA tentative approval for Saxagliptin Tablets, 2.5 mg and 5 mg

According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million


Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules
Drug Approval | December 20, 2022

Glenmark Pharmaceuticals receives ANDA approval for Nicardipine Hydrochloride Capsules

According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately US $10.9 million


Glenmark Pharmaceuticals launches Fingolimod Capsules in US
News | November 01, 2022

Glenmark Pharmaceuticals launches Fingolimod Capsules in US

According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion


Glenmark Pharmaceuticals expand its OTC portfolio
News | June 29, 2022

Glenmark Pharmaceuticals expand its OTC portfolio

The over-the-counter market has long been an important segment of Glenmark’s portfolio around the world


Glenmark Pharmaceuticals to address USFDA’s observation
News | June 23, 2022

Glenmark Pharmaceuticals to address USFDA’s observation

U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi


Glenmark Pharmaceuticals receives ANDA approval for metronidazole vaginal gel, 0.75%
Drug Approval | January 28, 2022

Glenmark Pharmaceuticals receives ANDA approval for metronidazole vaginal gel, 0.75%

Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA


Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection
Drug Approval | January 17, 2022

Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection

The company has 47 ANDA's pending approval with the U.S.FDA