KEY PRODUCTS
Inke S.A: APIs manufacturing plant.
01 1Inke S.A
01 1TETRABENAZINE
01 1Spain
01 1Active
01 1Complete
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2025-11-10
Pay. Date : 2025-09-24
DMF Number : 37218
Submission : 2022-06-21
Status : Active
Type : II
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Inke Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Inke S.A: APIs manufacturing plant.
One of their notable products is TETRABENAZINE, with a corresponding US DMF Number 37218.
Remarkably, this DMF maintains an Active status since its submission on June 21, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 10, 2025, and payment made on September 24, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
