01 1Teva Pharmaceutical Industries
01 1NERATINIB MALEATE MONOHYDRATE
01 1Israel
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-27
Pay. Date : 2020-12-17
DMF Number : 35457
Submission : 2021-01-11
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 NERATINIB MALEATE MONOHYDRATE, with a corresponding US DMF Number 35457.
Remarkably, this DMF maintains an Active status since its submission on January 11, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 27, 2021, and payment made on December 17, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
