Zydus Lifesciences Limited — Updates, 17-10-2024: Press Release

Zydus Lifesciences has received final USFDA approval to manufacture Fludrocortisone Acetate Tablets USP, 0.1 mg, indicated for treating adrenocortical insufficiency and salt-losing adrenogenital syndrome. The tablets will be produced at their Moraiya, Ahmedabad facility. This product had annual sales of approximately USD 19.9 million in the U.S. Zydus now holds a total of 400 approvals, having filed over 465 Abbreviated New Drug Applications since FY 2003-04.