01 1Natco Pharma
01 1LURBINECTEDIN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-23
Pay. Date : 2024-03-21
DMF Number : 37785
Submission : 2024-03-25
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 LURBINECTEDIN, with a corresponding US DMF Number 37785.
Remarkably, this DMF maintains an Active status since its submission on March 25, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2024, and payment made on March 21, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
