01 1Hetero Drugs
01 1AMIFAMPRIDINE PHOSPHATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-06
Pay. Date : 2022-09-15
DMF Number : 37447
Submission : 2022-09-14
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 AMIFAMPRIDINE PHOSPHATE, with a corresponding US DMF Number 37447.
Remarkably, this DMF maintains an Active status since its submission on September 14, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 06, 2022, and payment made on September 15, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
