01 1Hetero Drugs
01 1GEFITINIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-23
Pay. Date : 2018-01-04
DMF Number : 32274
Submission : 2017-12-28
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 GEFITINIB, with a corresponding US DMF Number 32274.
Remarkably, this DMF maintains an Active status since its submission on December 28, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 23, 2018, and payment made on January 04, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
