01 1Indoco Remedies Limited
01 1APIXABAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-06
Pay. Date : 2016-06-29
DMF Number : 30613
Submission : 2016-07-20
Status : Active
Type : II
20
Indoco Remedies 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 APIXABAN, with a corresponding US DMF Number 30613.
Remarkably, this DMF maintains an Active status since its submission on July 20, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 06, 2016, and payment made on June 29, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
