01 1Harman Finochem
01 1PHENYTOIN SODIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-14
Pay. Date : 2015-09-30
DMF Number : 17862
Submission : 2004-12-02
Status : Active
Type : II
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Harman Finochem Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is PHENYTOIN SODIUM USP, with a corresponding US DMF Number 17862.
Remarkably, this DMF maintains an Active status since its submission on December 02, 2004, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 14, 2015, and payment made on September 30, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
