Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
KEY PRODUCTS
KEY SERVICES
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01 1Honour Lab Limited
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01 1OSPEMIFENE
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01 1India
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01 1Active
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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 : 2016-12-07
Pay. Date : 2016-09-07
DMF Number : 30858
Submission : 2016-10-17
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 OSPEMIFENE, with a corresponding US DMF Number 30858.
Remarkably, this DMF maintains an Active status since its submission on October 17, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 07, 2016, and payment made on September 07, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II