01 1Morepen Laboratories
01 1LORATADINE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-28
Pay. Date : 2013-09-24
DMF Number : 12650
Submission : 1997-09-11
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, with a corresponding US DMF Number 12650.
Remarkably, this DMF maintains an Active status since its submission on September 11, 1997, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 28, 2013, and payment made on September 24, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
