01 1Shilpa Medicare
01 1GEMCITABINE HYDROCHLORIDE USP (PROCESS -2)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-01
Pay. Date : 2017-07-17
DMF Number : 31892
Submission : 2017-07-18
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 GEMCITABINE HYDROCHLORIDE USP (PROCESS -2), with a corresponding US DMF Number 31892.
Remarkably, this DMF maintains an Active status since its submission on July 18, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 01, 2017, and payment made on July 17, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
