Marksans Pharma Limited has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Benzonatate Capsules USP, available in 100 mg and 200 mg dosages. This approval marks a significant milestone for the company as it expands its portfolio of generic pharmaceutical formulations.
The Benzonatate Capsules developed by Marksans Pharma are bioequivalent and therapeutically equivalent to the reference listed drug, Tessalon Capsules, manufactured by Pfizer Inc. Benzonatate is a non-narcotic antitussive medication that works by numbing stretch receptors in the respiratory tract, thereby reducing the cough reflex. It is commonly used to relieve persistent coughs associated with conditions such as bronchitis, pneumonia, and other lung infections.
Marksans Pharma, headquartered in Mumbai, India, is engaged in the research, manufacturing, and marketing of generic pharmaceutical formulations across global markets. The company operates manufacturing facilities in India, the USA, and the UK, all of which have received approvals from leading regulatory agencies, including the USFDA, UKMHRA, and Australian TGA. Marksans Pharma’s product portfolio spans major therapeutic segments, including cardiovascular, central nervous system, anti-diabetic, pain management, upper respiratory, and gastroenterological treatments.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).