01 1Biocon
01 1RIVAROXABAN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-08
Pay. Date : 2020-11-27
DMF Number : 35387
Submission : 2020-12-31
Status : Active
Type : II
20
Biocon Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is RIVAROXABAN USP, with a corresponding US DMF Number 35387.
Remarkably, this DMF maintains an Active status since its submission on December 31, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 08, 2021, and payment made on November 27, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
