01 1Laurus Labs
01 1GEMCITABINE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-16
DMF Number : 22800
Submission : 2009-05-16
Status : Active
Type : II
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Laurus Labs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is GEMCITABINE HYDROCHLORIDE USP, with a corresponding US DMF Number 22800.
Remarkably, this DMF maintains an Active status since its submission on May 16, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 23, 2012, and payment made on November 16, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
