Marksans Pharma Gets USFDA Nod for Generic Tessalon Capsules
New Delhi: Marksans Pharma Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Benzonatate Capsules USP in strengths of 100 mg and 200 mg.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Tessalon Capsules (100 mg and 200 mg) marketed by Pfizer Inc.
Benzonatate is a non-narcotic antitussive indicated for the symptomatic relief of cough. It works by anesthetizing stretch receptors in the respiratory passages, lungs, and pleura, thereby suppressing the cough reflex. The drug is commonly used in conditions such as bronchitis, pneumonia, and other respiratory tract infections.
The approval strengthens Marksans Pharma’s portfolio in the U.S. generics market, particularly in the respiratory segment.
Marksans Pharma Limited, headquartered in Mumbai, is engaged in the research, manufacturing, and marketing of generic pharmaceutical formulations across global markets. The company operates manufacturing facilities in India, the United States, and the United Kingdom, which are approved by major regulatory authorities including the USFDA, UKMHRA, and Australia’s TGA.
The company has a diversified portfolio spanning multiple therapeutic segments, including cardiovascular, central nervous system, antidiabetic, pain management, upper respiratory, and gastrointestinal treatments, and continues to expand its presence in regulated markets.
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