Marksans Pharma Secures USFDA Approval for Benzonatate Capsules
Filing Summary
Marksans Pharma Ltd. has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Benzonatate Capsules USP, available in 100 mg and 200 mg dosages. These capsules are bioequivalent and therapeutically equivalent to Pfizer Inc.’s Tessalon Capsules. Benzonatate is a non-narcotic antitussive used to reduce cough reflexes. This approval allows Marksans Pharma to market the product in the United States. The company specializes in the research, manufacturing, and marketing of generic pharmaceutical formulations globally.
Marksans Pharma Ltd. has announced the final approval of its Abbreviated New Drug Application (ANDA) for Benzonatate Capsules USP, 100 mg and 200 mg, by the USFDA. This approval pertains to the bioequivalent and therapeutically equivalent version of the reference listed drug, Tessalon Capsules, 100 mg and 200 mg, manufactured by Pfizer Inc.
Benzonatate is classified as a non-narcotic antitussive. It functions by numbing stretch receptors in the respiratory tract, which reduces the cough reflex. This makes it suitable for relieving persistent cough associated with conditions such as bronchitis, pneumonia, or other lung infections.
The approval enables Marksans Pharma to market Benzonatate Capsules in the United States, expanding its product portfolio in the region. The company is engaged in the research, manufacturing, and marketing of generic pharmaceutical formulations across global markets.
Marksans Pharma Ltd. focuses on the development and distribution of generic pharmaceutical formulations. The company’s manufacturing facilities in India, USA, and UK are approved by leading regulatory agencies, including the USFDA, UKMHRA, and Australian TGA. Marksans Pharma’s product portfolio covers major therapeutic segments, including cardiovascular, central nervous system, anti-diabetic, pain management, upper respiratory, and gastroenterological areas. The company markets these products globally.