01 1GLAND PHARMA LIMITED
01 1FULVESTRANT USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-16
Pay. Date : 2015-09-28
DMF Number : 29787
Submission : 2015-09-28
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 FULVESTRANT USP, with a corresponding US DMF Number 29787.
Remarkably, this DMF maintains an Active status since its submission on September 28, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 16, 2016, and payment made on September 28, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
