01 1Macleods Pharmaceuticals Limited
01 1RIVAROXABAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-08
Pay. Date : 2018-06-21
DMF Number : 31783
Submission : 2017-07-03
Status : Active
Type : II
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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 RIVAROXABAN, with a corresponding US DMF Number 31783.
Remarkably, this DMF maintains an Active status since its submission on July 03, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 08, 2018, and payment made on June 21, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
