01 1Morepen Laboratories
01 1LORATADINE (PROCESS 2) U.S.P.
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-13
Pay. Date : 2014-11-05
DMF Number : 20669
Submission : 2007-07-11
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 LORATADINE (PROCESS 2) U.S.P., with a corresponding US DMF Number 20669.
Remarkably, this DMF maintains an Active status since its submission on July 11, 2007, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 13, 2014, and payment made on November 05, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
