01 1Hetero Drugs
01 1VERICIGUAT (FORM-I)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-14
Pay. Date : 2024-10-15
DMF Number : 40267
Submission : 2024-08-31
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 VERICIGUAT (FORM-I), with a corresponding US DMF Number 40267.
Remarkably, this DMF maintains an Active status since its submission on August 31, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 14, 2024, and payment made on October 15, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
