01 1Teva Pharmaceutical Industries
01 1SAMIDORPHAN L-MALATE
01 1Israel
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-02-04
Pay. Date : 2024-11-21
DMF Number : 40848
Submission : 2024-12-19
Status : Active
Type : II
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Tapi Nl Bv, based in Israel, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is SAMIDORPHAN L-MALATE, with a corresponding US DMF Number 40848.
Remarkably, this DMF maintains an Active status since its submission on December 19, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 04, 2025, and payment made on November 21, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
