Levofloxacin (as hemihydrate) 250mg tablets(Remington Pharmaceutical Industries [Pvt] Ltd),TB381

WHOPAR Part 7

December 2021

Steps before prequalificationI.

BACKGROUND INFORMATION ON THE PROCEDURE

1. Submission of the dossier
The company Remington Pharmaceutical Industries [Pvt] Ltd submitted in 2020 an application for[TB381 trade name]* (TB381) to be assessed with the aim of including [TB381 trade name] in the listof prequalified medicinal products for treatment of tuberculosis[TB381 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*November 2019

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

January 2020

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

February 2020

The applicant’s response letter was received.

March 2020

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

January and March2020

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

July 2020

The applicant’s response letter was received.

August 2020

The additional quality data were reviewed and further information was requested.

August 2020

The applicant’s response letter was received.

September 2020and January 2021

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

January 2021

The applicant’s response letter was received.

February 2021

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

February 2021

Product dossier accepted (quality assurance)

April 2021

The manufacturer of the FPP was inspected for compliance with WHO requirements for
GMP.
The analytical facilities, relevant for the acceptability of the biowaiver were inspected forcompliance with WHO requirements for GMP.

30 August 2021

[TB381 trade name] was included in the list of prequalified medicinal products.

Trade names are not prequalified by WHO. This is the national medicines regulatory authority’s responsibility.
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Levofloxacin (as hemihydrate) 250mg tablets(Remington Pharmaceutical Industries [Pvt] Ltd),
TB381

II.

WHOPAR Part 7

GENERAL CONDITIONS FOR THE PREQUALIFICATION

1. Manufacturer and Inspection status
Manufacturer of the finished product and responsible for batch release
Remington Pharmaceutical Industries (Pvt) Ltd
18km Multan Road,
Lahore 53800
PakistanInspection status
The sites were found to be in compliance with WHO requirements for GMP.
Not inspected for GCP/GLP since a biowaiver applies.

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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December 2021