01 1Hetero Drugs
01 1LISINOPRIL PROCESS-III
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-08
Pay. Date : 2023-03-16
DMF Number : 38132
Submission : 2023-03-03
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 LISINOPRIL PROCESS-III, with a corresponding US DMF Number 38132.
Remarkably, this DMF maintains an Active status since its submission on March 03, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 08, 2023, and payment made on March 16, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
