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Lupin in alliance with Natco receives USFDA approval for Bosentan Tablets

Lupin in alliance with Natco Pharma (Natco) has received approval for Bosentan Tablets, 62.5 mg and 125 mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Actelion Pharmaceuticals’ Tracleer Tablets, 62.5 mg and 125 mg.

The company and Natco’s Bosentan Tablets, 62.5 mg and 125 mg, is the generic version of Actelion Pharmaceuticals’ Tracleer Tablets, 62.5 mg and 125 mg. It is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and to decrease clinical worsening.

Bosentan Tablets, 62.5 mg and 125 mg had an annual sales of approximately $84.8 million in the US (IQVIA MAT March 2019).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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