01 1Aurobindo Pharma Limited
01 1SOLRIAMFETOL HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-28
Pay. Date : 2023-01-09
DMF Number : 37929
Submission : 2023-01-10
Status : Active
Type : II
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Apitoria Pharma Private 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 SOLRIAMFETOL HYDROCHLORIDE, with a corresponding US DMF Number 37929.
Remarkably, this DMF maintains an Active status since its submission on January 10, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 28, 2023, and payment made on January 09, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
