01 1Aurobindo Pharma Limited
01 1AUROPAP 90F (ACETAMINOPHEN DIRECTLY COMPRESSIBLE GRANULES)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-16
Pay. Date : 2025-08-08
DMF Number : 42293
Submission : 2025-08-02
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 AUROPAP 90F (ACETAMINOPHEN DIRECTLY COMPRESSIBLE GRANULES), with a corresponding US DMF Number 42293.
Remarkably, this DMF maintains an Active status since its submission on August 02, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 16, 2025, and payment made on August 08, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
