Natco Pharma Gets USFDA Approval for Bosentan 32mg Tablets

12 Feb 2025 , 11:14 AM

Natco Pharma Ltd has received final approval from the USFDA to market Bosentan 32mg tablets. This drug, Bosentan 32mg tablets is used for the treatment of pulmonary arterial hypertension (PAH). This drug is usable for children aged 3 years and above. This provides an opportunity for the company to market a generic equivalent of Tracleer, a drug produced by Actelion Pharmaceuticals US Inc.

The drug enhances the flow of blood through the lungs, allowing children with PAH to breathe and improve their ability to engage in physical activity. Lupin Pharmaceuticals Inc., Natco’s U.S. marketing partner, will market the drug, and the drug will be made available to patients across the country.

The company is pursuing a claim to First-to-File status, which would grant it the exclusive right to market the drug for 180 days, but plans for launch are not yet available. The 32mg oral suspension of Bosentan registered U.S. sales of $11 million in the previous year, indicating a profitable business venture for Natco. This approval is another milestone for Natco Pharma’s expansion in the U.S. market, solidifying its position in the global pharma industry.

Besides this, Natco Pharma sold 14.38 acres of land at Ranga Reddy, Telangana, for ₹115.57 crore in November 2024, which forms a part of its financial and business plan. Hyderabad-based Natco Pharma is a leading generic, branded, and specialty medicines company with strong presence in active pharmaceutical ingredients (APIs). The company has nine plant facilities and two R&D facilities in India and has approvals from major regulatory authorities, including USFDA, Brazil ANVISA, and Health Canada, and exports to more than 50 international markets.