01 1Aurobindo Pharma Limited
01 1TRANDOLAPRIL USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-12
Pay. Date : 2017-10-26
DMF Number : 19548
Submission : 2006-06-21
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 TRANDOLAPRIL USP, with a corresponding US DMF Number 19548.
Remarkably, this DMF maintains an Active status since its submission on June 21, 2006, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 12, 2017, and payment made on October 26, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
