01 1Aurobindo Pharma Limited
01 1PANTOPRAZOLE SODIUM USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-24
Pay. Date : 2024-02-20
DMF Number : 39597
Submission : 2024-03-29
Status : Active
Type : II
20
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 PANTOPRAZOLE SODIUM USP (PROCESS-II), with a corresponding US DMF Number 39597.
Remarkably, this DMF maintains an Active status since its submission on March 29, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 24, 2024, and payment made on February 20, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
