01 1Shilpa Medicare
01 1TENOFOVIR ALAFENAMIDE FUMARATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-14
Pay. Date : 2019-05-16
DMF Number : 33850
Submission : 2019-05-17
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 TENOFOVIR ALAFENAMIDE FUMARATE, with a corresponding US DMF Number 33850.
Remarkably, this DMF maintains an Active status since its submission on May 17, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 14, 2019, and payment made on May 16, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
