01 1Aurobindo Pharma Limited
01 1DUTASTERIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-07-28
DMF Number : 29577
Submission : 2015-07-31
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 DUTASTERIDE USP, with a corresponding US DMF Number 29577.
Remarkably, this DMF maintains an Active status since its submission on July 31, 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 July 28, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
