01 1Sun Pharmaceutical Industries Limited
01 1APIXABAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-22
Pay. Date : 2016-09-06
DMF Number : 30788
Submission : 2016-09-23
Status : Active
Type : II
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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 APIXABAN, with a corresponding US DMF Number 30788.
Remarkably, this DMF maintains an Active status since its submission on September 23, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 22, 2016, and payment made on September 06, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
