KEY PRODUCTS
Inke S.A: APIs manufacturing plant.
01 1Inke S.A
01 1TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)
01 1Spain
01 1Active
01 1Complete
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-30
Pay. Date : 2020-01-13
DMF Number : 34410
Submission : 2020-03-17
Status : Active
Type : II
20
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 TIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED), with a corresponding US DMF Number 34410.
Remarkably, this DMF maintains an Active status since its submission on March 17, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 30, 2021, and payment made on January 13, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
