01 1Apothecon Pharmaceuticals
01 1PHYTONADIONE USP (PROCESS A)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-06
Pay. Date : 2016-09-20
DMF Number : 30910
Submission : 2016-09-20
Status : Active
Type : II
20
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 PHYTONADIONE USP (PROCESS A), with a corresponding US DMF Number 30910.
Remarkably, this DMF maintains an Active status since its submission on September 20, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 06, 2017, and payment made on September 20, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
