KEY PRODUCTS
Inke S.A: APIs manufacturing plant.
01 1Inke S.A
01 1INDACATEROL MALEATE (MICRONIZED AND NON-MICRONIZED)
01 1Spain
01 1Active
01 1Complete
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2025-01-29
Pay. Date : 2024-12-09
DMF Number : 34411
Submission : 2024-06-25
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 INDACATEROL MALEATE (MICRONIZED AND NON-MICRONIZED), with a corresponding US DMF Number 34411.
Remarkably, this DMF maintains an Active status since its submission on June 25, 2024, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 29, 2025, and payment made on December 09, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
