Marksans Receives USFDA Approval For Guaifenesin Extended-Release Tablets

Marksans Pharma Ltd., one of the fastest-growing pharmaceutical companies in India, is pleased to announce that it 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 company on Tuesday announced through an exchange filing.

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.

“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," said Mark Saldanha, Managing Director of the Company.

Marksans Pharma Ltd shares

The shares of Marksans Pharma Ltd on Tuesday at 2:52 pm IST were at Rs 112.60, up by 2.64 percent.