01 1Nortec Quimica
01 1ESKETAMINE HYDROCHLORIDE
01 1Brazil
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-22
Pay. Date : 2023-01-31
DMF Number : 37647
Submission : 2022-12-09
Status : Active
Type : II
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Nortec Quimica Sa, based in Brazil, is a pharmaceutical company that stands out with its certifications from FDA.
They are recognized for Nortec Quimica is the largest API manufacturer in Latin America.
One of their notable products is ESKETAMINE HYDROCHLORIDE, with a corresponding US DMF Number 37647.
Remarkably, this DMF maintains an Active status since its submission on December 09, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 22, 2023, and payment made on January 31, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
