01 1Aurobindo Pharma Limited
01 1SIPONIMOD FUMARIC ACID
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-12-16
Pay. Date : 2022-11-15
DMF Number : 37679
Submission : 2022-11-16
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 SIPONIMOD FUMARIC ACID, with a corresponding US DMF Number 37679.
Remarkably, this DMF maintains an Active status since its submission on November 16, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 16, 2022, and payment made on November 15, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
