01 1Aurobindo Pharma Limited
01 1ESOMEPRAZOLE MAGNESIUM DIHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-08
Pay. Date : 2013-03-18
DMF Number : 26239
Submission : 2012-08-01
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, with a corresponding US DMF Number 26239.
Remarkably, this DMF maintains an Active status since its submission on August 01, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 08, 2013, and payment made on March 18, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
