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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 : 2024-11-21

Pay. Date : 2024-10-18

DMF Number : 40335

Submission : 2024-09-27

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 40335 of Honour Lab Limited

Looking for Drug Master Files (DMF) for 40335 of Honour Lab Limited 1

20

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 FOSFOMYCIN TROMETHAMINE, with a corresponding US DMF Number 40335.

Remarkably, this DMF maintains an Active status since its submission on September 27, 2024, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 21, 2024, and payment made on October 18, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II