Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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KEY SERVICES
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01 1Honour Lab Limited
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01 1ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
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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 : 2021-10-25
Pay. Date : 2021-09-14
DMF Number : 36283
Submission : 2021-09-30
Status : Active
Type : II
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Honour Lab Limited, 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 ERTUGLIFLOZIN L-PYROGLUTAMIC ACID, with a corresponding US DMF Number 36283.
Remarkably, this DMF maintains an Active status since its submission on September 30, 2021, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 25, 2021, and payment made on September 14, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II