01 1Hetero Drugs
01 1ARIPIPRAZOLE PROCESS-I
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-04
Pay. Date : 2017-07-10
DMF Number : 31455
Submission : 2017-03-04
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 ARIPIPRAZOLE PROCESS-I, with a corresponding US DMF Number 31455.
Remarkably, this DMF maintains an Active status since its submission on March 04, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 04, 2017, and payment made on July 10, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
