India Pharma Outlook Team | Wednesday, 01 April 2026
Marksans Pharma gets USFDA nod for benzonatate capsules, marking a key step in its push into the US generics market.
The company announced today that it has received final approval from the US Food and Drug Administration for its generic benzonatate capsules in 100 mg and 200 mg strengths.
This USFDA approval for benzonatate capsules allows Marksans Pharma to expand its respiratory product portfolio in the United States.
Benzonatate capsules are used as a cough suppressant, helping reduce the urge to cough by numbing the throat and lungs. The approved product is a generic version of Tessalon capsules, originally developed by Pfizer, and is widely prescribed for conditions such as bronchitis and other respiratory infections.
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With this latest Marksans Pharma USFDA approval for benzonatate capsules, the company strengthens its presence in a highly competitive but lucrative market. The US remains one of the largest markets for generic drugs, offering significant growth potential for companies that secure regulatory clearances.
Marksans Pharma said the approval aligns with its strategy to broaden its product pipeline and increase its footprint in regulated markets. The addition of benzonatate capsules is expected to support revenue growth, although pricing pressure and competition in the generics space remain key challenges.
The announcement also had an immediate impact on investor sentiment, with the company’s shares gaining momentum following the news. Market participants view the development as a positive signal of Marksans Pharma’s regulatory and manufacturing capabilities.
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