Zydus Life gets USFDA approval for Lubiprostone capsules

Lubiprostone capsules, 8 mcg and 24 mcg, have received final approval from the US Food and Drug Administration (USFDA), according to Zydus Lifesciences. The aforementioned medication is equivalent to the reference listed medication, Amitiza capsules. It is prescribed to treat specific types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation). The drug will be manufactured in Moraiya, Ahmedabad, at the group’s formulation manufacturing facility (India). Lubiprostone capsules (8 mcg and 24 mcg) had $196.5 million in annual sales in the United States (IQVIA MAT, January 2023). Furthermore, Doxepin Hydrochloride capsules USP, 150 mg received final USFDA approval.

Doxepin Hydrochloride capsule is used to treat mental/emotional issues like depression and anxiety. It improves moods and feelings of well-being, alleviates anxiety and tension, promotes better sleep, and boosts energy levels. The drug in question will be produced at the group’s formulation manufacturing facility in Moraiya, Ahmedabad. As of December 31, 2022, the group had 354 approvals and had filed over 440 ANDAs since the filing process began in FY 2003-04. Zydus Lifesciences is a global lifesciences company focused on discovery that discovers, develops, manufactures, and markets a wide range of healthcare therapies.

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