01 1Shilpa Medicare
01 1IMATINIB MESYLATE (IMN)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-25
Pay. Date : 2014-07-01
DMF Number : 28349
Submission : 2014-06-27
Status : Active
Type : II
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Shilpa Pharma Lifesciences 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 (IMN), with a corresponding US DMF Number 28349.
Remarkably, this DMF maintains an Active status since its submission on June 27, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 25, 2015, and payment made on July 01, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
