01 1Intas Pharmaceuticals
01 1DOFETILIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-20
Pay. Date : 2018-10-29
DMF Number : 33305
Submission : 2018-11-26
Status : Active
Type : II
20
Intas Pharmaceuticals 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 DOFETILIDE USP, with a corresponding US DMF Number 33305.
Remarkably, this DMF maintains an Active status since its submission on November 26, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 20, 2018, and payment made on October 29, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
