KEY PRODUCTS
Inke S.A: APIs manufacturing plant.
01 1Inke S.A
01 1OLODATEROL HYDROCHLORIDE
01 1Spain
01 1Active
01 1Complete
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-23
Pay. Date : 2023-07-12
DMF Number : 38558
Submission : 2023-07-21
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 OLODATEROL HYDROCHLORIDE, with a corresponding US DMF Number 38558.
Remarkably, this DMF maintains an Active status since its submission on July 21, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 23, 2023, and payment made on July 12, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
