Indian pharmaceutical powerhouse, Marksans Pharma has achieved a significant milestone, securing the coveted US Food and Drug Administration (FDA) nod for its Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets in both 600 mg and 1200 mg concentrations.

These breakthrough tablets are confirmed to be bioequivalent to the acclaimed Mucinex Extended-Release Tablets of the same doses, a flagship product of RB Health (US) LLC. Notably, Guaifenesin extended-release tablets are proficient in alleviating bronchial discomfort by loosening phlegm, thinning bronchial secretions, and thereby enhancing the productivity of coughs.

With this monumental approval under its belt, Marksans Pharma is poised to swiftly launch the product in the market. Reflecting on this achievement, Mark Saldanha, the Managing Director of Marksans Pharma, voiced his enthusiasm. “This FDA approval fortifies our robust foothold in the US Cough and Cold OTC sector. We are well-positioned to maximize the vast market potential this product offers,” Saldanha remarked.

This development cements Marksans Pharma’s reputation as one of India’s rapidly progressing pharmaceutical entities, continually striving for innovation and excellence in the global healthcare arena.

  Guaifenesin Extended-Release Tablets, Mark Saldanha, Marksans Pharma, Mucinex, US FDA, US Food and Drug Administration, USA