01 1Aurobindo Pharma Limited
01 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-13
Pay. Date : 2015-05-26
DMF Number : 29389
Submission : 2015-05-30
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 ESOMEPRAZOLE MAGNESIUM DIHYDRATE (PROCESS II), with a corresponding US DMF Number 29389.
Remarkably, this DMF maintains an Active status since its submission on May 30, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 13, 2015, and payment made on May 26, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
