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US FDA gives tentative approval to Zydus Lifesciences for Bosentan tabs, oral suspension

US FDA gives tentative approval to  Zydus Lifesciences for Bosentan tabs, oral suspension

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (US FDA) to market Bosentan Tablets for Oral Suspension, 32 mg.

Bosentan Tablet for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) in patients aged three years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR). The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.

The group now has 341 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

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USFDA Zydus Lifesciences
More news about: quality / gmp | Published by Sudeep Soparkar | February - 16 - 2023 | 504

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