01 1Shilpa Medicare
01 1BICALUTAMIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-04
Pay. Date : 2013-09-23
DMF Number : 24690
Submission : 2011-05-11
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 BICALUTAMIDE USP, with a corresponding US DMF Number 24690.
Remarkably, this DMF maintains an Active status since its submission on May 11, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 04, 2014, and payment made on September 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
