01 1Hetero Drugs
01 1DORAVIRINE PREMIX
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-09
Pay. Date : 2022-06-17
DMF Number : 37216
Submission : 2022-06-23
Status : Active
Type : II
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Hetero Labs 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 DORAVIRINE PREMIX, with a corresponding US DMF Number 37216.
Remarkably, this DMF maintains an Active status since its submission on June 23, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 09, 2022, and payment made on June 17, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
