Zydus Lifesciences Dexamethasone Tablets bags USFDA okay
Ahmedabad: Zydus Lifesciences Limited has announced that the Company has received final approval from the United States Food and Drug Administration (USFDA) to market Dexamethasone Tablets USP, 1 mg.
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 MAT March 24). The group now has 395 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.
Furthermore, in the same month, Zydus Lifesciences Limited also received final approval from the USFDA to distribute Dapsone Gel, 7.5% (USRLD: Aczone Gel 7.5%).
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Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer-related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R&D.
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