01 1Shilpa Medicare
01 1IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-09
Pay. Date : 2012-12-18
DMF Number : 23562
Submission : 2010-02-23
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 IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP, with a corresponding US DMF Number 23562.
Remarkably, this DMF maintains an Active status since its submission on February 23, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 09, 2013, and payment made on December 18, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
