01 1GLAND PHARMA LIMITED
01 1SUGAMMADEX SODIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-12
Pay. Date : 2021-04-29
DMF Number : 34233
Submission : 2019-10-31
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 SUGAMMADEX SODIUM, with a corresponding US DMF Number 34233.
Remarkably, this DMF maintains an Active status since its submission on October 31, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 12, 2021, and payment made on April 29, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
