01 1Laurus Labs
01 1MACITENTAN
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-12
Pay. Date : 2017-08-30
DMF Number : 31957
Submission : 2017-09-15
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 MACITENTAN, with a corresponding US DMF Number 31957.
Remarkably, this DMF maintains an Active status since its submission on September 15, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 12, 2017, and payment made on August 30, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
