01 1Laurus Labs
01 1SITAGLIPTIN PHOSPHATE MONOHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-30
Pay. Date : 2021-02-03
DMF Number : 35584
Submission : 2021-03-16
Status : Active
Type : II
20
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 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP, with a corresponding US DMF Number 35584.
Remarkably, this DMF maintains an Active status since its submission on March 16, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 30, 2021, and payment made on February 03, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
