01 1GLAND PHARMA LIMITED
01 1ARGATROBAN MONOHYDRATE (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-15
Pay. Date : 2014-11-28
DMF Number : 28030
Submission : 2014-05-15
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 (PROCESS-II), with a corresponding US DMF Number 28030.
Remarkably, this DMF maintains an Active status since its submission on May 15, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 15, 2014, and payment made on November 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
