01 1Aurobindo Pharma Limited
01 1IVACAFTOR
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-13
Pay. Date : 2021-07-07
DMF Number : 36094
Submission : 2021-07-07
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 IVACAFTOR, with a corresponding US DMF Number 36094.
Remarkably, this DMF maintains an Active status since its submission on July 07, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 13, 2021, and payment made on July 07, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
