01 1Shilpa Medicare
01 1BORTEZOMIB
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-25
Pay. Date : 2022-05-20
DMF Number : 36821
Submission : 2022-03-09
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 BORTEZOMIB, with a corresponding US DMF Number 36821.
Remarkably, this DMF maintains an Active status since its submission on March 09, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 25, 2022, and payment made on May 20, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II
