01 1GLAND PHARMA LIMITED
01 1LEVOCARNITINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-27
Pay. Date : 2024-03-13
DMF Number : 39168
Submission : 2023-11-27
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 LEVOCARNITINE, with a corresponding US DMF Number 39168.
Remarkably, this DMF maintains an Active status since its submission on November 27, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 27, 2024, and payment made on March 13, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
