01 1GLAND PHARMA LIMITED
01 1ARGATROBAN MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-12
Pay. Date : 2013-03-26
DMF Number : 25400
Submission : 2011-10-27
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 ARGATROBAN MONOHYDRATE USP, with a corresponding US DMF Number 25400.
Remarkably, this DMF maintains an Active status since its submission on October 27, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 12, 2013, and payment made on March 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
