01 1Shilpa Medicare
01 1IMATINIB MESYLATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-03-19
DMF Number : 27927
Submission : 2014-03-28
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, with a corresponding US DMF Number 27927.
Remarkably, this DMF maintains an Active status since its submission on March 28, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 07, 2014, and payment made on March 19, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
