01 1Alembic Pharmaceuticals Limited
01 1GEFITINIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-13
Pay. Date : 2016-09-08
DMF Number : 30868
Submission : 2016-09-19
Status : Active
Type : II
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Alembic Pharmaceuticals 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 30868.
Remarkably, this DMF maintains an Active status since its submission on September 19, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 13, 2016, and payment made on September 08, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
