Linezolid 150 mg dispersible tablets(Macleods Pharmaceuticals Limited),
TB391

WHOPAR Part 7May 2023

Steps before prequalificationI.

BACKGROUND INFORMATION ON THE PROCEDURE

1. Submission of the dossier
The company Macleods Pharmaceuticals Limited submitted in 2021 an application for [TB391 tradename]* (TB391) to be assessed with the aim of including [TB391 trade name] in the list ofprequalified medicinal products for treatment of drug-resistant tuberculosis caused by Mycobacterium
tuberculosis.
[TB391 trade name] was assessed according to the ‘Procedure for Assessing the Acceptability, inPrinciple, of Pharmaceutical Products for Purchase by United Nations Agencies’ by the team ofWHO assessors. The assessors are senior experts, mainly from national authorities, invited by WHO
to participate in the prequalification assessment process.
2. Steps taken in the evaluation of the product*August 2020

A desk review for evaluation of compliance of the manufacturer of the API for GMP wasconducted and it met WHO requirements.

September 2020

A desk review for evaluation of compliance for the bioequivalence study for GLP and GCP
met WHO requirements.

September 2021

During the meeting of the assessment team the safety and efficacy data were reviewed andfurther information was requested

September andNovember 2021

During the meetings of the assessment team the quality data were reviewed and further
information was requested.

November 2021

The applicant’s response letter was received.

November 2021

During the meeting of the assessment team the additional safety and efficacy data werereviewed and further information was requested.

November 2021

The manufacturer of the FPP was inspected for compliance with WHO requirements forGMP.

December 2021

The applicant’s response letter was received.

January 2022

The applicant’s response letter was received.

January 2022

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.
The safety and efficacy data were reviewed and found to comply with the relevant WHO
requirements.

May 2022

The applicant’s response letter was received.

May 2022

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.

June 2022

The applicant’s response letter was received.

July 2022

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.

August 2022

The applicant’s response letter was received.

Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s responsibility.
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Linezolid 150 mg dispersible tablets(Macleods Pharmaceuticals Limited),
TB391

II.

WHOPAR Part 7

May 2023

September 2022

During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.

October 2022

The applicant’s response letter was received.

October 2022

The quality data were reviewed and found to comply with the relevant WHO requirements.

November 2022

Product dossier accepted (quality assurance)

14 November 2022

[TB391 trade name] was included in the list of prequalified medicinal products.

GENERAL CONDITIONS FOR THE PREQUALIFICATION

1. Manufacturer and Inspection status
Manufacturer of the finished product and responsible for batch release
Macleods Pharmaceuticals Limited,
Plot No.50 to 54A,
SEZ, Phase II
Pithampur,Dist.: Dhar
Madhya Pradesh, 454774
India
Inspection status
Desk review of the API site found it to be in compliance with WHO requirements for GMP.
The FPP site inspected was found to be in compliance with WHO requirements for GMP.
Desk review of the CRO found it to be in compliance with WHO requirements for GCP/GLP.
2. (Advice on) Conditions or restrictions regarding supply and use
Medicinal product subject to medical prescription.
Further information is available at:https://extranet.who.int/pqweb/medicines/prequalified-lists/finished-pharmaceutical-products

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