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01 1Honour Lab Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

GDUFA

DMF Review : Complete

Rev. Date : 2018-01-04

Pay. Date : 2017-08-08

DMF Number : 31895

Submission : 2017-11-28

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 31895 of Honour Lab Ltd

Looking for Drug Master Files (DMF) for 31895 of Honour Lab Ltd 1

20

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 AZILSARTAN KAMEDOXOMIL, with a corresponding US DMF Number 31895.

Remarkably, this DMF maintains an Active status since its submission on November 28, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 04, 2018, and payment made on August 08, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II