01 1Morepen Laboratories
01 1ATORVASTATIN CALCIUM TRIHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-25
Pay. Date : 2017-03-16
DMF Number : 26351
Submission : 2012-08-23
Status : Active
Type : II
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Morepen Laboratories 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 ATORVASTATIN CALCIUM TRIHYDRATE, with a corresponding US DMF Number 26351.
Remarkably, this DMF maintains an Active status since its submission on August 23, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 25, 2017, and payment made on March 16, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
