01 1Macleods Pharmaceuticals Limited
01 1TENOFOVIR ALAFENAMIDE FUMARATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-31
Pay. Date : 2019-07-11
DMF Number : 33941
Submission : 2019-06-29
Status : Active
Type : II
20
Macleods Pharmaceuticals 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 33941.
Remarkably, this DMF maintains an Active status since its submission on June 29, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 31, 2019, and payment made on July 11, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
