01 1Hetero Drugs
01 1APALUTAMIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-29
Pay. Date : 2021-11-17
DMF Number : 36394
Submission : 2021-11-24
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 APALUTAMIDE, with a corresponding US DMF Number 36394.
Remarkably, this DMF maintains an Active status since its submission on November 24, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 29, 2021, and payment made on November 17, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
