01 1Aurobindo Pharma Limited
01 1MIGALASTAT HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-08
Pay. Date : 2022-02-25
DMF Number : 36827
Submission : 2022-02-25
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 MIGALASTAT HYDROCHLORIDE, with a corresponding US DMF Number 36827.
Remarkably, this DMF maintains an Active status since its submission on February 25, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 08, 2022, and payment made on February 25, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
