01 1GLAND PHARMA LIMITED
01 1TIROFIBAN HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-05
Pay. Date : 2013-09-12
DMF Number : 23173
Submission : 2009-10-07
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 TIROFIBAN HYDROCHLORIDE, with a corresponding US DMF Number 23173.
Remarkably, this DMF maintains an Active status since its submission on October 07, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 05, 2014, and payment made on September 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
