01 1Natco Pharma
01 1THIOTEPA
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-08
Pay. Date : 2019-01-28
DMF Number : 31104
Submission : 2017-05-05
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 THIOTEPA, with a corresponding US DMF Number 31104.
Remarkably, this DMF maintains an Active status since its submission on May 05, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 08, 2019, and payment made on January 28, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
