01 1Hetero Drugs
01 1ABEMACICLIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-23
Pay. Date : 2025-09-17
DMF Number : 41395
Submission : 2025-05-22
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 ABEMACICLIB, with a corresponding US DMF Number 41395.
Remarkably, this DMF maintains an Active status since its submission on May 22, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 23, 2025, and payment made on September 17, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
