01 1Chemeca Drugs
01 1QUETIAPINE FUMARATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-18
Pay. Date : 2023-07-17
DMF Number : 37315
Submission : 2022-07-26
Status : Active
Type : II
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Chemeca Drugs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is QUETIAPINE FUMARATE USP, with a corresponding US DMF Number 37315.
Remarkably, this DMF maintains an Active status since its submission on July 26, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 18, 2023, and payment made on July 17, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
