01 1Hetero Drugs
01 1RIFAXIMIN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-02-19
Pay. Date : 2025-01-17
DMF Number : 40982
Submission : 2024-12-31
Status : Active
Type : II
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Hetero Drugs 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 RIFAXIMIN, with a corresponding US DMF Number 40982.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 19, 2025, and payment made on January 17, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
