01 1Hetero Drugs
01 1ASCIMINIB HYDROCHLORIDE PREMIX
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-17
Pay. Date : 2025-07-29
DMF Number : 42298
Submission : 2025-07-29
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 ASCIMINIB HYDROCHLORIDE PREMIX, with a corresponding US DMF Number 42298.
Remarkably, this DMF maintains an Active status since its submission on July 29, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 17, 2025, and payment made on July 29, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
