01 1Hetero Drugs
01 1PIOGLITAZONE HYDROCHLORIDE (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-03-02
DMF Number : 30333
Submission : 2016-03-03
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 PIOGLITAZONE HYDROCHLORIDE (PROCESS-II), with a corresponding US DMF Number 30333.
Remarkably, this DMF maintains an Active status since its submission on March 03, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 28, 2016, and payment made on March 02, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
