01 1Apothecon Pharmaceuticals
01 1MIGLUSTAT
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-29
Pay. Date : 2023-09-07
DMF Number : 36453
Submission : 2021-11-10
Status : Active
Type : II
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Navinta Llc, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Apothecon- Your trusted partner for APIs & HPAPIs// Emerging leader in therapeutic generic drugs.
One of their notable products is MIGLUSTAT, with a corresponding US DMF Number 36453.
Remarkably, this DMF maintains an Active status since its submission on November 10, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 29, 2023, and payment made on September 07, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
