01 1Intas Pharmaceuticals
01 1RIVAROXABAN FORM- I (MICRONIZED)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-19
Pay. Date : 2016-05-25
DMF Number : 30562
Submission : 2016-06-08
Status : Active
Type : II
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Intas 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 FORM- I (MICRONIZED), with a corresponding US DMF Number 30562.
Remarkably, this DMF maintains an Active status since its submission on June 08, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 19, 2016, and payment made on May 25, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
