01 1Hetero Drugs
01 1AFATINIB DIMALEATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-30
Pay. Date : 2017-04-28
DMF Number : 31611
Submission : 2017-04-11
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 AFATINIB DIMALEATE, with a corresponding US DMF Number 31611.
Remarkably, this DMF maintains an Active status since its submission on April 11, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 30, 2017, and payment made on April 28, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
