01 1Nortec Quimica
01 1BUPIVACAINE
01 1Brazil
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-25
Pay. Date : 2018-11-13
DMF Number : 33285
Submission : 2018-11-21
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 BUPIVACAINE, with a corresponding US DMF Number 33285.
Remarkably, this DMF maintains an Active status since its submission on November 21, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 25, 2019, and payment made on November 13, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
