01 1Hetero Drugs
01 1BEROTRALSTAT DIHYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-05
Pay. Date : 2024-09-13
DMF Number : 40411
Submission : 2024-09-18
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 BEROTRALSTAT DIHYDROCHLORIDE, with a corresponding US DMF Number 40411.
Remarkably, this DMF maintains an Active status since its submission on September 18, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 05, 2024, and payment made on September 13, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
