Zydus Lifesciences Limited has recently announced exchanges that the company received final approval from the United States Food and Drug Administration (USFDA) for the manufacture of Fludrocortisone Acetate Tablets USP, 0.1 mg.
Fludrocortisone acetate tablets are used as a partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease, as well as to treat salt-losing adrenogenital syndrome. Fludrocortisone acetate tablets will be manufactured at the company’s facility in Moraiya, Ahmedabad.
The company presently has 400 approvals and has submitted over 465* ANDAs since the beginning of the filing process in FY 2003-04.
