01 1Shilpa Medicare
01 1AXITINIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-05
Pay. Date : 2015-12-23
DMF Number : 30104
Submission : 2015-12-24
Status : Active
Type : II
20
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 AXITINIB, with a corresponding US DMF Number 30104.
Remarkably, this DMF maintains an Active status since its submission on December 24, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 05, 2016, and payment made on December 23, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
