01 1Hetero Drugs
01 1IRBESARTAN (FORM A) PROCESS I
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-27
Pay. Date : 2016-05-12
DMF Number : 17507
Submission : 2004-07-02
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 IRBESARTAN (FORM A) PROCESS I, with a corresponding US DMF Number 17507.
Remarkably, this DMF maintains an Active status since its submission on July 02, 2004, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 27, 2016, and payment made on May 12, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
