01 1Aurobindo Pharma Limited
01 1ENTECAVIR
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-10
Pay. Date : 2013-08-27
DMF Number : 27401
Submission : 2013-08-31
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 ENTECAVIR, with a corresponding US DMF Number 27401.
Remarkably, this DMF maintains an Active status since its submission on August 31, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 10, 2013, and payment made on August 27, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
