01 1Hetero Drugs
01 1ENZALUTAMIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-02-24
Pay. Date : 2025-01-17
DMF Number : 36053
Submission : 2021-10-21
Status : Active
Type : II
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Hetero Labs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is ENZALUTAMIDE, with a corresponding US DMF Number 36053.
Remarkably, this DMF maintains an Active status since its submission on October 21, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 24, 2025, and payment made on January 17, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
