01 1Hetero Drugs
01 1RUFINAMIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-07
Pay. Date : 2021-07-13
DMF Number : 36077
Submission : 2021-08-18
Status : Active
Type : II
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Hetero Drugs 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 RUFINAMIDE, with a corresponding US DMF Number 36077.
Remarkably, this DMF maintains an Active status since its submission on August 18, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 07, 2021, and payment made on July 13, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
