01 1Aurobindo Pharma Limited
01 1ABIRATERONE ACETATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-25
Pay. Date : 2022-09-22
DMF Number : 37529
Submission : 2022-09-23
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 ABIRATERONE ACETATE USP, with a corresponding US DMF Number 37529.
Remarkably, this DMF maintains an Active status since its submission on September 23, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 25, 2022, and payment made on September 22, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
