01 1Signa S.A. de C.V.
01 1PONATINIB HYDROCHLORIDE
01 1Mexico
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-29
Pay. Date : 2020-11-27
DMF Number : 35413
Submission : 2020-12-16
Status : Active
Type : II
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Zhejiang Lepu Pharmaceutical Co Ltd, based in Mexico, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is PONATINIB HYDROCHLORIDE, with a corresponding US DMF Number 35413.
Remarkably, this DMF maintains an Active status since its submission on December 16, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 29, 2021, and payment made on November 27, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
