Zydus Lifesciences gets tentative USFDA approval for Dexamethasone Tablets USP, 1 mg
Ahmedabad: Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) to manufacture and market Dexamethasone Tablets USP, 1 mg (USRLD: Dexamethasone Tablets).
Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders.
The product will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh.
Dexamethasone Tablets USP, 1 mg had annual sales of USD 1.8 mn in the United States (IQVIA Dec. Nov. 2023). The group now has 387 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.
The Company has also received final approvals from the USFDA to manufacture and market Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg (USRLD: Decadron Tablets) and Dexamethasone Tablets USP, 2 mg (USRLD: Dexamethasone Tablets).
Formerly known as Cadila Healthcare Limited, Zydus Lifesciences Limited is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the production of generic drugs. Cadila was founded in 1952 by Ramanbhai Patel.
