01 1Unichem Laboratories Limited
01 1QUETIAPINE FUMARATE (QPT PROCESS)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-23
Pay. Date : 2020-08-21
DMF Number : 35130
Submission : 2020-08-26
Status : Active
Type : II
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Unichem Laboratories 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 (QPT PROCESS), with a corresponding US DMF Number 35130.
Remarkably, this DMF maintains an Active status since its submission on August 26, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 23, 2020, and payment made on August 21, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
