Marksans Pharma Receives USFDA Approval for Benzonatate Capsules
Marksans Pharma Limited (Reuters: MARK.BO; Bloomberg: MRKS IN; NSE: MARKSANS; BSE: 524404) announced the final approval of its Abbreviated New Drug Application (ANDA) for Benzonatate Capsules USP, 100 mg & 200 mg (Rx) from the US Food and Drug Administration (USFDA).The approved product is bioequivalent and therapeutically equivalent to Tessalon Capsules, 100 mg and 200 mg, manufactured by Pfizer Inc. Benzonatate is a non-narcotic antitussive used to relieve persistent cough associated with bronchitis, pneumonia, or other lung infections.
Marksans Pharma Limited, headquartered in Mumbai, India, is engaged in the research, manufacturing, and marketing of generic pharmaceutical formulations in global markets. The company operates manufacturing facilities in India, the USA, and the UK, approved by regulatory agencies including the USFDA, UKMHRA, and Australian TGA. Its product portfolio spans therapeutic segments including cardiovascular, central nervous system, antidiabetic, pain management, upper respiratory, and gastroenterological.
Source:
Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
The information provided is for general informational purposes only and does not constitute investment advice, a recommendation, or an offer to buy or sell any securities. Readers are advised to rely on their own assessment and judgment and consult appropriate financial advisers, if required, before taking any investment-related decisions.