01 1Hetero Drugs
01 1DAROLUTAMIDE PREMIX
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-13
Pay. Date : 2023-04-25
DMF Number : 38274
Submission : 2023-05-02
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 DAROLUTAMIDE PREMIX, with a corresponding US DMF Number 38274.
Remarkably, this DMF maintains an Active status since its submission on May 02, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 13, 2023, and payment made on April 25, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
