01 1Hetero Drugs
01 1QUETIAPINE FUMARATE (PROCESS II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-14
Pay. Date : 2016-08-18
DMF Number : 25770
Submission : 2012-02-09
Status : Active
Type : II
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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 QUETIAPINE FUMARATE (PROCESS II), with a corresponding US DMF Number 25770.
Remarkably, this DMF maintains an Active status since its submission on February 09, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 14, 2016, and payment made on August 18, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
