01 1GLAND PHARMA LIMITED
01 1EPINEPHRINE (LOW EPIMER)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-05
Pay. Date : 2023-09-29
DMF Number : 38733
Submission : 2023-09-27
Status : Active
Type : II
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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 EPINEPHRINE (LOW EPIMER), with a corresponding US DMF Number 38733.
Remarkably, this DMF maintains an Active status since its submission on September 27, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 05, 2023, and payment made on September 29, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
