01 1Hetero Drugs
01 1IMATINIB MESYLATE (FORM-A)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-11
Pay. Date : 2013-03-05
DMF Number : 26687
Submission : 2012-12-07
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 IMATINIB MESYLATE (FORM-A), with a corresponding US DMF Number 26687.
Remarkably, this DMF maintains an Active status since its submission on December 07, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 11, 2013, and payment made on March 05, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
