01 1Hetero Drugs
01 1EPLERENONE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-16
Pay. Date : 2019-09-24
DMF Number : 33832
Submission : 2019-05-20
Status : Active
Type : II
20
Hetero Labs 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 EPLERENONE, with a corresponding US DMF Number 33832.
Remarkably, this DMF maintains an Active status since its submission on May 20, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 16, 2019, and payment made on September 24, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
