01 1Dipharma SA
01 1MIGALASTAT HYDROCHLORIDE
01 1Switzerland
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-25
Pay. Date : 2025-08-26
DMF Number : 42278
Submission : 2025-07-29
Status : Active
Type : II
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Dipharma Sa, based in Switzerland, is a pharmaceutical company.
One of their notable products is MIGALASTAT HYDROCHLORIDE, with a corresponding US DMF Number 42278.
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 25, 2025, and payment made on August 26, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
