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Glenmark Pharmaceuticals receives ANDA approval for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials

Mumbai, India; June 23, 2021: Glenmark Pharmaceuticals Ltd (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials, the generic version of BROVANA^®1 Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc. 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, and marks the company’s first nebulizer approval.

According to IQVIA^TM sales data for the 12 month period ending April 2021, the BROVANA Inhalation Solution, 15 mcg/2 mL market² achieved annual sales of approximately $437.9 million*.

Commenting on the launch, Sanjeev Krishan, President, Glenmark North America said, “We are very excited to be one of the first generic companies to receive approval for such an important product for our customers. This also marks our third approval from our state-of-the art manufacturing facility in Monroe in 2021, demonstrating our capability to offer high quality medicines with affordable access across multiple dosage platforms.”
Glenmark’s current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the U.S. 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.

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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. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It ranks among the world’s top 50 Generics and Biosimilars companies (Top 50 Company Rankings, 2020, from Informa’s 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 world’s 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 www.glenmarkpharma.com

For more information, please contact:

Udaykumar Murthy
Senior Manager: Corporate Communications
Glenmark, Mumbai, India
+91 9960377617
corpcomm@glenmarkpharma.com

¹All brand names and trademarks are the property of their respective owners
²Market includes brand and all available therapeutic equivalents
*IQVIA^TM National Sales Perspectives: Retail & Non-Retail, April 2021

Glenmark Pharmaceuticals receives ANDA approval for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials

Mumbai, India; June 23, 2021: Glenmark Pharmaceuticals Ltd (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vials, the generic version of BROVANA^®1 Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc. 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, and marks the company’s first nebulizer approval.

According to IQVIA^TM sales data for the 12 month period ending April 2021, the BROVANA Inhalation Solution, 15 mcg/2 mL market² achieved annual sales of approximately $437.9 million*.

Commenting on the launch, Sanjeev Krishan, President, Glenmark North America said, “We are very excited to be one of the first generic companies to receive approval for such an important product for our customers. This also marks our third approval from our state-of-the art manufacturing facility in Monroe in 2021, demonstrating our capability to offer high quality medicines with affordable access across multiple dosage platforms.”
Glenmark’s current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the U.S. 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.

--End--

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. Glenmark’s key therapy focus areas globally are respiratory, dermatology and oncology. It ranks among the world’s top 50 Generics and Biosimilars companies (Top 50 Company Rankings, 2020, from Informa’s 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 world’s 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 www.glenmarkpharma.com

For more information, please contact:

Udaykumar Murthy
Senior Manager: Corporate Communications
Glenmark, Mumbai, India
+91 9960377617
corpcomm@glenmarkpharma.com

¹All brand names and trademarks are the property of their respective owners
²Market includes brand and all available therapeutic equivalents
*IQVIA^TM National Sales Perspectives: Retail & Non-Retail, April 2021