01 1Hetero Drugs
01 1DARUNAVIR AMORPHOUS (PROCESS-II)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-10
Pay. Date : 2021-04-16
DMF Number : 35834
Submission : 2021-04-10
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 DARUNAVIR AMORPHOUS (PROCESS-II), with a corresponding US DMF Number 35834.
Remarkably, this DMF maintains an Active status since its submission on April 10, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 10, 2021, and payment made on April 16, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
