Glenmark Pharma gets approval for Arformoterol Tartrate Inhalation Solution

Glenmark Pharmaceuticals on Wednesday received final approval from the USFDA for Arformoterol Tartrate inhalation solution, 15 mcg/2 mL.

Arformoterol Tartrate inhalation solution is generic version of BROVANA inhalation solution of Sunovion Pharmaceuticals Inc. Arformoterol Tartrate inhalation solution 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 sales data for the 12 month period ended April 2021, the BROVANA Inhalation Solution market achieved annual sales of approximately $437.9 million.

Commenting on the launch, Sanjeev Krishan, president of Glenmark North America said, We are one of the first generic companies to receive approval. This marks our third approval from our manufacturing facility in Monroe in 2021.

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.

Shares of Glenmark Pharmaceuticals were trading 0.46% higher at Rs 643.65 on BSE.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries.

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