01 1Aurobindo Pharma Limited
01 1SITAGLIPTIN PHOSPHATE ANHYDROUS USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-03-13
Pay. Date : 2025-01-21
DMF Number : 41070
Submission : 2025-01-31
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 SITAGLIPTIN PHOSPHATE ANHYDROUS USP (PROCESS-II), with a corresponding US DMF Number 41070.
Remarkably, this DMF maintains an Active status since its submission on January 31, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 13, 2025, and payment made on January 21, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
