01 1Aurobindo Pharma Limited
01 1RANOLAZINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-06-25
DMF Number : 29483
Submission : 2015-06-26
Status : Active
Type : II
20
Apitoria Pharma Private 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 RANOLAZINE, with a corresponding US DMF Number 29483.
Remarkably, this DMF maintains an Active status since its submission on June 26, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2015, and payment made on June 25, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
