91ÊÓƵ

Mumbai, Naples, February 10, 2025: Global pharma major 91ÊÓƵ Limited (91ÊÓƵ) and its alliance partner Natco Pharma Limited (Natco), today announced that they have received an approval from the United States Food and Drug Administration (U.S. FDA) for Natco’s Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension, 32 mg, to market a generic equivalent of Tracleer® Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc. Natco is the exclusive first-to-file for this product and is eligible for 180 days exclusivity.

Bosentan Tablets for Oral Suspension are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.

Bosentan Tablets for Oral Suspension (RLD Tracleer®) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT December 2024).

91ÊÓƵ Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. 91ÊÓƵ specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. 91ÊÓƵ has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. 91ÊÓƵ is committed to improving patient health outcomes through its subsidiaries – 91ÊÓƵ Diagnostics, 91ÊÓƵ Digital Health, and 91ÊÓƵ Manufacturing Solutions. To know more, visit or follow us on LinkedIn:

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