Glenmark receives ANDA approval for inhalation solution

Glenmark receives ANDA approval for inhalation solution

By: IPP Bureau

Last updated : August 03, 2021 7:04 pm



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


Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (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 sales data for the 12 month period ending April 2021, the BROVANA Inhalation Solution, 15 mcg/2 mL market achieved annual sales of approximately US $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 Pharmaceuticals Sanjeev Krishan

First Published : June 24, 2021 12:00 am