Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Tablets USP 50 mg 100 mg 150 mg and 200 mg \
3 min read
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Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Tablets USP 50 mg 100 mg 150 mg and 200 mg

21-Mar-2022
MUMBAI India March 21 2022 PRNewswire -- Glenmark Pharmaceuticals Inc USA Glenmark has received final approval by the United States Food Drug Administration US FDA for its Lacosamide Tablets1 USP 50 mg 100 mg 150 mg and 200 mg the generic version of Vimpat2 Tablets 50 mg 100 mg 150 mg and 200 mg of UCB Inc The company plans to launch the product immediately Commenting on the development Robert Crockart Chief Commercial Officer Glenmark Pharmaceuticals Ltd said The FDA approval for generic Lacosamide Tablets USP reiterates our ongoing commitment to make treatment options more accessible for patients We look forward to quickly launching this product in the US market According to IQVIA sales data for the 12 month period ending January 2022 the Vimpat Tablets 50 mg 100 mg 150 mg and 200 mg market3 achieved annual sales of approximately 17 billion Glenmarks current portfolio consists of 174 products authorized for distribution in the US marketplace and 45 ANDAs pending approval with the US FDA In addition to these internal filings Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio About Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Glenmark is a global innovation-driven pharmaceutical company with presence across Specialty Generics and OTC businesses Globally Glenmark focuses on the following key therapy areas respiratory dermatology and oncology The company has 10 world-class manufacturing facilities spread across 4 continents and operations in over 80 countries It was ranked among the worlds top 50 Generics and Biosimilars companies Top 50 Company Rankings 2020 from Informas Generics Bulletin The company has been listed on the Dow Jones Sustainability Index DJSI under the category of emerging markets for the fourth consecutive year in a row most recently in 2021 DJSI is one of the worlds most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index wwwglenmarkpharmacom References 1Glenmarks Lacosamide Tablets are only approved for their FDA-approved indication 2All brand names and trademarks are the property of their respective owners 3Market includes brand and all available therapeutic equivalents IQVIA National Sales Perspectives Retail Non-Retail January 2022 Logo httpsmmaprnewswirecommedia451507PRNEGlenmarkLogojpg PWR PWR
21-Mar-2022 National
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Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg and 200 mg \
3 min read
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Glenmark Pharmaceuticals receives ANDA approval for Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg and 200 mg

21-Mar-2022
Mumbai (Maharashtra) [India], March 21 (ANI/PR Newswire): Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for its Lacosamide Tablets1 USP, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat®2 Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB, Inc.
21-Mar-2022 Business
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Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe \
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Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe

17-Jan-2022
Mumbai (Maharashtra) [India], January 17 (ANI/PRNewswire): Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the generic version of Lexiscan®1 Injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US, Inc.
17-Jan-2022 Business
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Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Phosphate Foam 1 \
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Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Phosphate Foam 1

21-Sep-2021
MUMBAI India Sept 21 2021 PRNewswire -- Glenmark Pharmaceuticals Ltd Glenmark has received final approval by the United States Food Drug Administration US FDA for Clindamycin Phosphate Foam 1 the generic version of Evoclin1 Foam 1 of Mylan Pharmaceuticals Inc According to IQVIATM sales data for the 12 month period ending July 2021 the Evoclin Foam 1 market2 achieved annual sales of approximately 120 million Glenmarks current portfolio consists of 173 products authorized for distribution in the US marketplace and 47 ANDAs pending approval with the US FDA In addition to these internal filings Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio References 1All brand names and trademarks are the property of their respective owners 2Market includes brand and all available therapeutic equivalents IQVIATM National Sales Perspectives Retail Non-Retail July 2021 About Glenmark Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd GPL is a global research-led pharmaceutical company with presence across Generics Specialty and OTC business with operations in over 50 countries Glenmarks key therapy focus areas globally are respiratory dermatology and oncology It ranks among the worlds top 50 Generics and Biosimilars companies Top 50 Company Rankings 2020 from Informas Generics Bulletin The company has been listed in the Dow Jones Sustainability Index DJSI under the category of emerging markets for the third consecutive year in a row DJSI is one of the worlds most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index For more information visit wwwglenmarkpharmacom Logo httpmmaprnewswirecommedia451507PRNEGlenmarkLogojpg PWR PWR
21-Sep-2021 National
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Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Phosphate Foam, 1% \
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Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Phosphate Foam, 1%

21-Sep-2021
Mumbai (Maharashtra) [India], September 21 (ANI/PR Newswire): Glenmark Pharmaceuticals Ltd. (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Clindamycin Phosphate Foam, 1%, the generic version of Evoclin®1 Foam, 1%, of Mylan Pharmaceuticals Inc.
21-Sep-2021 Business
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