01 1Emcure Pharmaceuticals
01 1HYDROXYZINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-06
Pay. Date : 2024-11-29
DMF Number : 39539
Submission : 2024-03-04
Status : Active
Type : II
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Emcure Pharmaceuticals 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 HYDROXYZINE HYDROCHLORIDE USP, with a corresponding US DMF Number 39539.
Remarkably, this DMF maintains an Active status since its submission on March 04, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 06, 2025, and payment made on November 29, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
