01 1Hetero Drugs
01 1TRILACICLIB DIHYDROCHLORIDE DIHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-08
Pay. Date : 2024-11-14
DMF Number : 40409
Submission : 2024-11-13
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 TRILACICLIB DIHYDROCHLORIDE DIHYDRATE, with a corresponding US DMF Number 40409.
Remarkably, this DMF maintains an Active status since its submission on November 13, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2025, and payment made on November 14, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
