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 1SAPROPTERIN DIHYDROCHLORIDE
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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 : 2019-09-20
Pay. Date : 2019-07-26
DMF Number : 33928
Submission : 2019-08-06
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 SAPROPTERIN DIHYDROCHLORIDE, with a corresponding US DMF Number 33928.
Remarkably, this DMF maintains an Active status since its submission on August 06, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 20, 2019, and payment made on July 26, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II