Zydus Lifesciences Limited announced that the company has received final approval for Lubiprostone Capsules, 8 mcg and 24 mcg, from the United States Food and Drug Administration (USFDA), via an exchnage filing.
Lubiprostone capsule is indicated to treat certain types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation).
The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
Lubiprostone Capsules, 8 mcg and 24 mcg had annual sales of USD 196.5 mn in the United States (IQVIA MAT, January 2023). The group now has 354 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.
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