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 1APIXABAN
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 : 2016-07-05
Pay. Date : 2016-04-26
DMF Number : 30461
Submission : 2016-05-18
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 APIXABAN, with a corresponding US DMF Number 30461.
Remarkably, this DMF maintains an Active status since its submission on May 18, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 05, 2016, and payment made on April 26, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
