01 1GLAND PHARMA LIMITED
01 1INDOMETHACIN SODIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-22
Pay. Date : 2014-11-28
DMF Number : 27282
Submission : 2013-10-24
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 INDOMETHACIN SODIUM USP, with a corresponding US DMF Number 27282.
Remarkably, this DMF maintains an Active status since its submission on October 24, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 22, 2014, and payment made on November 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
