01 1Shilpa Medicare
01 1IBRUTINIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-02
Pay. Date : 2017-10-12
DMF Number : 32122
Submission : 2017-10-04
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 IBRUTINIB, with a corresponding US DMF Number 32122.
Remarkably, this DMF maintains an Active status since its submission on October 04, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 02, 2017, and payment made on October 12, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
