01 1Morepen Laboratories
01 1SITAGLIPTIN PHOSPHATE MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2026-01-14
Pay. Date : 2025-12-03
DMF Number : 33517
Submission : 2019-01-17
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 SITAGLIPTIN PHOSPHATE MONOHYDRATE, with a corresponding US DMF Number 33517.
Remarkably, this DMF maintains an Active status since its submission on January 17, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 14, 2026, and payment made on December 03, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
