01 1Apothecon Pharmaceuticals
01 1SEVELAMER CARBONATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2014-01-02
DMF Number : 27405
Submission : 2014-01-02
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 SEVELAMER CARBONATE, with a corresponding US DMF Number 27405.
Remarkably, this DMF maintains an Active status since its submission on January 02, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 28, 2014, and payment made on January 02, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
