01 1Laurus Labs
01 1ATORVASTATIN CALCIUM TRIHYDRATE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-05
Pay. Date : 2018-01-02
DMF Number : 32214
Submission : 2018-07-18
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 ATORVASTATIN CALCIUM TRIHYDRATE USP, with a corresponding US DMF Number 32214.
Remarkably, this DMF maintains an Active status since its submission on July 18, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 05, 2018, and payment made on January 02, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
