01 1Aurobindo Pharma Limited
01 1RALTEGRAVIR POTASSIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-14
Pay. Date : 2023-12-22
DMF Number : 39315
Submission : 2023-12-30
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 RALTEGRAVIR POTASSIUM USP, with a corresponding US DMF Number 39315.
Remarkably, this DMF maintains an Active status since its submission on December 30, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 14, 2024, and payment made on December 22, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
