01 1Hetero Drugs
01 1MILNACIPRAN HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-12
Pay. Date : 2012-12-07
DMF Number : 26515
Submission : 2012-10-01
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 MILNACIPRAN HYDROCHLORIDE, with a corresponding US DMF Number 26515.
Remarkably, this DMF maintains an Active status since its submission on October 01, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 12, 2013, and payment made on December 07, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
