01 1Shilpa Medicare
01 1ENZALUTAMIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2016-03-08
DMF Number : 30260
Submission : 2016-03-17
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 ENZALUTAMIDE, with a corresponding US DMF Number 30260.
Remarkably, this DMF maintains an Active status since its submission on March 17, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 13, 2016, and payment made on March 08, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
