01 1GLAND PHARMA LIMITED
01 1FOSPHENYTOIN SODIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-09
Pay. Date : 2019-04-24
DMF Number : 33756
Submission : 2019-04-29
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 FOSPHENYTOIN SODIUM, with a corresponding US DMF Number 33756.
Remarkably, this DMF maintains an Active status since its submission on April 29, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 09, 2019, and payment made on April 24, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
