01 1Aurobindo Pharma Limited
01 1CEFDINIR USP (ANHYDROUS)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-19
Pay. Date : 2024-02-23
DMF Number : 39540
Submission : 2024-03-25
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 CEFDINIR USP (ANHYDROUS), with a corresponding US DMF Number 39540.
Remarkably, this DMF maintains an Active status since its submission on March 25, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 19, 2024, and payment made on February 23, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
