Marksans Pharma Mucus loosening drug Guaifenesin ER bags USFDA okay
Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Mumbai: Marksans Pharma Ltd. has announced that the company has received final approval from the US Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application ("ANDA") for Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC).
The Guaifenesin Extended-Release Tablets, 600 mg and 1200 mg (OTC) are bioequivalent to the reference listed drug (RLD), Mucinex Extended-Release Tablets, 600 mg and 1200 mg, of RB Health (US) LLC.
Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
The company expects to launch the product immediately.
Commenting on the approval, Mark Saldanha, Managing Director of the Company said, “We are delighted to announce the approval, which further strengthens our growing Cough and Cold OTC portfolio in the US. We are confident in tapping the market opportunity of the product and remain committed to working diligently towards sustaining this momentum in the coming quarters.”
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Marksans Pharma Ltd. headquartered in Mumbai, India is engaged in the Research, Manufacturing & Marketing of generic pharmaceutical formulations in the global markets. The company's manufacturing facilities are approved by several leading regulatory agencies including USFDA, UKMHRA, and Australian TGA. The company's robust product portfolio spreads over major therapeutic segments of CVS, CNS, Antidiabetic, Pain Management, Gastroenterological, and Anti-allergies. The company is marketing these products globally.
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