01 1Shilpa Medicare
01 1TRANEXAMIC ACID USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-04
Pay. Date : 2018-09-04
DMF Number : 33086
Submission : 2018-09-05
Status : Active
Type : II
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Shilpa Pharma Lifesciences 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 TRANEXAMIC ACID USP, with a corresponding US DMF Number 33086.
Remarkably, this DMF maintains an Active status since its submission on September 05, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2018, and payment made on September 04, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
