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  • Natco Pharma gets...

Natco Pharma gets final approval for Bosentan tablets for oral suspension

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-02-10T11:30:46+05:30  |  Updated On 10 Feb 2025 11:30 AM IST
Natco Pharma announces key leadership appointments across quality, operations, regulatory, distribution teams
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Hyderabad: NATCO Pharma Limited has announced final approval of its Abbreviated New Drug Application (ANDA) for Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer by Actelion Pharmaceuticals US Inc.

NATCO’s marketing partner for the ANDA, Lupin Pharmaceuticals, Inc. will market the product in the U.S.

"NATCO believes it has sole First-to-File status for the product and is eligible for a 180-day exclusivity at the time of launch. Launch details are bound by confidentiality," the Compay stated.

Bosentan TFOS is 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 (TFOS), 32mg had estimated sales of USD 11 million in the U.S. for 12 months ending Sep’24 as per industry sales data.

Read also: Natco Pharma gets approval for Everolimus tablets for Oral Suspension for subependymal giant cell astrocytoma

NATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven, leading Oncology player in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company’s manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.

Read also: Natco Pharma appoints Madhava Rao Karicherla as Associate Vice President - Formulation RnD, Pharma Division, Kothur Unit

natco pharmanatco pharma newsbosentan tabletstracleeractelion pharmalupinpulmonary arterial hypertension
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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