01 1Ipca Laboratories
01 1QUETIAPINE FUMARATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-08
Pay. Date : 2013-06-17
DMF Number : 21009
Submission : 2007-12-14
Status : Active
Type : II
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Ipca 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, with a corresponding US DMF Number 21009.
Remarkably, this DMF maintains an Active status since its submission on December 14, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 08, 2013, and payment made on June 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
