01 1Chemeca Drugs
01 1FLUOXETINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2026-01-29
Pay. Date : 2025-09-26
DMF Number : 42668
Submission : 2025-09-30
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 FLUOXETINE HYDROCHLORIDE USP, with a corresponding US DMF Number 42668.
Remarkably, this DMF maintains an Active status since its submission on September 30, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 29, 2026, and payment made on September 26, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
