01 1Sun Pharmaceutical Industries Limited
01 1DOFETILIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-23
Pay. Date : 2016-09-30
DMF Number : 31026
Submission : 2016-11-19
Status : Active
Type : II
20
Sun Pharmaceutical Industries 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 31026.
Remarkably, this DMF maintains an Active status since its submission on November 19, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 23, 2016, and payment made on September 30, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
