01 1Aurobindo Pharma Limited
01 1TENOFOVIR DISOPROXIL FUMARATE (NON-STERILE DRUG SUBSTANCE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-01
Pay. Date : 2017-10-10
DMF Number : 21096
Submission : 2007-11-23
Status : Active
Type : II
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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 TENOFOVIR DISOPROXIL FUMARATE (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 21096.
Remarkably, this DMF maintains an Active status since its submission on November 23, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 01, 2017, and payment made on October 10, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
