01 1Emnar Pharma
01 1PITOLISANT HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-22
Pay. Date : 2024-07-25
DMF Number : 39126
Submission : 2023-12-05
Status : Active
Type : II
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Emnar Pharma Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is PITOLISANT HYDROCHLORIDE, with a corresponding US DMF Number 39126.
Remarkably, this DMF maintains an Active status since its submission on December 05, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 22, 2024, and payment made on July 25, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
