Isoniazid/Rifampicin 50mg/75mg
Dispersible Tablets(Macleods Pharmaceuticals Limited), TB302

WHOPAR Part 7

October 2021

Steps before prequalificationI.

BACKGROUND INFORMATION ON THE PROCEDURE

1.

Submission of the dossier

The company Macleods Pharmaceuticals Limited submitted in 2015 an application for [TB302 tradename] (TB302) to be assessed with the aim of including [TB302 trade name] in the list of prequalified
medicinal products for the treatment of tuberculosis.
[TB302 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 of WHOassessors. The assessors are senior experts, mainly from national authorities, invited by WHO toparticipate in the prequalification assessment process.
2.

Steps taken for the assessment of the productMarch 2014

The manufacturer of one API was inspected for compliance with WHO requirements for
GMP.
May 2014
The manufacturer of the FPP was inspected for compliance with WHO requirements for
GMP.
Jan 2015
During the meeting of the assessment team the safety and efficacy data were reviewed
and further information was requested.
March 2015
The company’s response letter was received.
March 2015
During the meeting of the assessment team the additional efficacy data and the quality
data were reviewed and further information was requested.
April 2015
The company’s response letter was received.
May 2015
During the meeting of the assessment team the additional efficacy data were reviewed
and further information was requested.
June 2016
The manufacturer of one API was inspected for compliance with WHO requirements for
GMP.
July 2015
The manufacturer of one API was inspected for compliance with WHO requirements for
GMP.
Aug 2016
The manufacturer of one API was inspected for compliance with WHO requirements for
GMP.
Sept 2015
The company’s response letter was received.
Nov 2015
During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.
Nov 2015
The manufacturer of one API was inspected for compliance with WHO requirements for
GMP.
Jan 2016
The company’s response letter was received.
Jan 2016
During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.
Feb and March The company’s response letters were received.
2016
March 2016
During the meeting of the assessment team the additional efficacy data and the additional
quality data were reviewed and further information was requested.
Sept 2016
In between the meetings of the assessment team the company’s response letter wasreceived. The additional safety and efficacy data were reviewed and further information

Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s (NMRA)
responsibility.
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Isoniazid/Rifampicin 50mg/75mg
Dispersible Tablets(Macleods Pharmaceuticals Limited), TB302

Aug 2016
Sept 2016
Nov 2016
Nov 2016

Feb 2017
March 2017
May and July2017
July 2017
July 2017
Aug 2017
31 Aug 2017

IIWHOPAR Part 7

October 2021

was requested.
The company’s response letter was received.
During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.
The company’s response letters were received.
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.
The company’s response letter was received.
During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.
The company’s response letters were received.
The quality data were reviewed and found to comply with the relevant
WHO requirements.
The sites relevant for the bioequivalence study were inspected for compliance with WHO
requirements for GLP and GCP.
Product dossier accepted (quality assurance)[TB302 trade name] was included in the list of prequalified medicinal products.

GENERAL CONDITIONS FOR THE PREQUALIFICATION

1. Manufacturer, commitments and Inspection status
Manufacturers of the finished product and responsible for batch release:

Oxalis Labs
Village ThedaP.O. Lodhimajra, Baddi
Distt. Solan

Macleods Pharmaceuticals Limited
Unit II, Phase II
Plot No 25-27, Survey No 366
Premier Industrial Estate
Kachigam, Daman, 369 210
India

Himachal Pradesh, 174101
India

Commitments for Prequalification
None which have an impact on the benefit-risk profile of the medicinal productInspection status
The sites inspected were found to be compliant with WHO requirements for GMP, GCP and 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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