Marksans Pharma Limited has informed the Exchange regarding a press release dated April 01, 2026, titled "USFDA approval for Benzonatate Capsules USP, 100 mg & 200 mg (Rx)".
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Marksans Pharma Limited has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Benzonatate Capsules in 100 mg and 200 mg strengths. The product is a generic version of Pfizer's Tessalon Capsules and is bioequivalent and therapeutically equivalent to the reference listed drug. Benzonatate is a non-narcotic antitussive used to relieve persistent cough associated with bronchitis, pneumonia, or other lung infections. This approval allows Marksans to manufacture and market this generic medication in the US market. The company has manufacturing facilities in India, USA, and UK approved by major regulatory agencies including USFDA.
The USFDA approval opens a new revenue opportunity for Marksans Pharma in the US generic pharmaceutical market for cough/cold treatments, though no specific revenue projections or market share estimates were disclosed.