01 1GLAND PHARMA LIMITED
01 1EDARAVONE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-29
Pay. Date : 2020-11-23
DMF Number : 35028
Submission : 2020-08-20
Status : Active
Type : II
20
Gland 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 EDARAVONE, with a corresponding US DMF Number 35028.
Remarkably, this DMF maintains an Active status since its submission on August 20, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 29, 2020, and payment made on November 23, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
