01 1Natco Pharma
01 1NILOTINIB HYDROCHLORIDE MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-12-15
Pay. Date : 2022-10-27
DMF Number : 36308
Submission : 2022-12-02
Status : Active
Type : II
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Natco Pharma 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 NILOTINIB HYDROCHLORIDE MONOHYDRATE, with a corresponding US DMF Number 36308.
Remarkably, this DMF maintains an Active status since its submission on December 02, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 15, 2022, and payment made on October 27, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
