01 1Aurobindo Pharma Limited
01 1ESOMEPRAZOLE SODIUM (NON-STERILE DRUG SUBSTANCE)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-23
Pay. Date : 2012-12-26
DMF Number : 26102
Submission : 2012-09-07
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 SODIUM (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 26102.
Remarkably, this DMF maintains an Active status since its submission on September 07, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 23, 2013, and payment made on December 26, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
