01 1Shilpa Medicare
01 1ERLOTINIB HYDROCHLORIDE (ET)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-04-10
DMF Number : 29124
Submission : 2015-04-13
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 ERLOTINIB HYDROCHLORIDE (ET), with a corresponding US DMF Number 29124.
Remarkably, this DMF maintains an Active status since its submission on April 13, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 04, 2015, and payment made on April 10, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
