01 1Shilpa Medicare
01 1BENDAMUSTINE HCL
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-20
Pay. Date : 2012-12-19
DMF Number : 25222
Submission : 2011-11-08
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 BENDAMUSTINE HCL, with a corresponding US DMF Number 25222.
Remarkably, this DMF maintains an Active status since its submission on November 08, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 20, 2013, and payment made on December 19, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
