01 1Aurobindo Pharma Limited
01 1MESALAMINE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-15
Pay. Date : 2019-06-04
DMF Number : 33910
Submission : 2019-06-05
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 MESALAMINE USP, with a corresponding US DMF Number 33910.
Remarkably, this DMF maintains an Active status since its submission on June 05, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 15, 2019, and payment made on June 04, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
