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Zydus Lifesciences gets USFDA’s final approval for Lubiprostone Capsules

24 Mar 2023 Evaluate

Zydus Lifesciences has received final approval for Lubiprostone Capsules, 8 mcg and 24 mcg (USRLD: Amitiza Capsules) from the United States Food and Drug Administration (USFDA).

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 $196.5 million 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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

Zydus Lifesciences Share Price

942.00 -0.55 (-0.06%)
20-Apr-2026 10:07 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1672.10
Dr. Reddys Lab 1238.50
Cipla 1237.90
Zydus Lifesciences 942.00
Lupin 2334.30
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