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Results For "U.S.-market"

117 News Found

BI Sky Global successfully completes FDA MoCRA registration
Drug Approval | August 25, 2024

BI Sky Global successfully completes FDA MoCRA registration

MoCRA mandates that all facilities involved in the manufacturing and processing of cosmetic products for sale in the United States


Granules India receives ANDA approval for Glycopyrrolate Oral Solution
Drug Approval | August 20, 2024

Granules India receives ANDA approval for Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients


Granules India receives ANDA approval for Trazodone Tablets
Drug Approval | August 11, 2024

Granules India receives ANDA approval for Trazodone Tablets

Trazodone tablets are indicated for the treatment of major depressive disorder in adults


Briefs: Zydus Lifesciences and Divi's Laboratories
Drug Approval | July 22, 2024

Briefs: Zydus Lifesciences and Divi's Laboratories

Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets


Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules
Drug Approval | June 12, 2024

Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules

Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace


Heuron gets FDA green light for stroke triage and notification solution
News | May 25, 2024

Heuron gets FDA green light for stroke triage and notification solution

This marks the first FDA approval of an AI-based brain disorder analysis solution from Korea


Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution
Drug Approval | May 18, 2024

Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution

According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million


Dr. Reddy's Laboratories launches Doxycycline Capsules, 40 mg in US
Drug Approval | May 06, 2024

Dr. Reddy's Laboratories launches Doxycycline Capsules, 40 mg in US

ORACEA is a trademark of Galderma Holdings, S.A.


Granules India announced ANDA Approval for Colchicine Capsules
Drug Approval | May 01, 2024

Granules India announced ANDA Approval for Colchicine Capsules

Colchicine Capsules are indicated for prophylaxis of gout flares in adult


Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets
Drug Approval | April 29, 2024

Glenmark receives ANDA approval for acetaminophen and ibuprofen tablets

Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA