01 1Hetero Drugs
01 1BELUMOSUDIL MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-25
Pay. Date : 2025-04-22
DMF Number : 41719
Submission : 2025-04-29
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 BELUMOSUDIL MESYLATE, with a corresponding US DMF Number 41719.
Remarkably, this DMF maintains an Active status since its submission on April 29, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 25, 2025, and payment made on April 22, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
