KEY PRODUCTS
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
01 1Honour Lab Limited
01 1ATOGEPANT MONOHYDRATE
01 1India
01 1Active
01 1Complete
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-07
Pay. Date : 2025-07-09
DMF Number : 42258
Submission : 2025-07-31
Status : Active
Type : II
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Honour Lab Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
One of their notable products is ATOGEPANT MONOHYDRATE, with a corresponding US DMF Number 42258.
Remarkably, this DMF maintains an Active status since its submission on July 31, 2025, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 07, 2025, and payment made on July 09, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II
