Artesunate 100mg+Mefloquine(as hydrochloride) 200 mg Tablets,(Cipla Ltd), MA079

WHOPAR part 7I

BACKGROUND INFORMATION ON THE PROCEDURE

1.

Submission of the dossier

December 2012

The company Cipla Ltd submitted in 2010 an application for Artesunate/Mefloquine 100/200mg FDC(Fixed Dose Combination) Cipla Tablets * (MA079) to be assessed with the aim of including
Artesunate/Mefloquine 100/200mg FDC (Fixed Dose Combination) Cipla Tablets in the list ofprequalified medicinal products for the treatment of Malaria.
Artesunate and mefloquine tablets were assessed according to the ‘Procedure for Assessing theAcceptability, in principle, of Pharmaceutical Products for purchase by United Nations Agencies’ by
the team of WHO assessors. The assessors are senior experts, mainly from national authorities, invitedby WHO to participate in the prequalification assessment process. The countries of origin of theassessors involved with Artesunate/Mefloquine 100/200mg FDC (Fixed Dose Combination) CiplaTablets are Canada, Germany, Netherlands, South Africa, Spain, Sweden and Switzerland.
Licensing status:
Artesunate/Mefloquine 100/200mg FDC (Fixed Dose Combination) Cipla Tablets have been licensed /registered in the following countries:• India MF-589/2011• Malaysia MAL12035082A• Myanmar 1709AA4815
2.

Steps taken for the assessment of the productMarch 2010

During the meeting of the assessment team the safety and efficacy data were reviewed
and further information was requested.
July 2010
Safety and efficacy data have been reviewed and further information was requested.
Aug 2010
The company’s response letters were received.
June – Oct 2010 During the meetings of the assessment team, the additional safety and efficacy data werereviewed and further information was requested.
Dec 2010
The company’s response letters were received.
Jan 2011
During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.
Feb 2011
The manufacturer of the API 1 was inspected for compliance with WHO requirements for
GMP.
Feb 2011
The manufacturer of the FPP was inspected for compliance with WHO requirements for
GMP.
March 2011
During the meeting of the assessment team the additional safety and efficacy data werereviewed and further information was requested.
June 2011
The company’s response letters were received.
July 2011
During the meeting of the assessment team the additional safety and efficacy and quality
data were reviewed and further information was requested.
Sept 2011
The company’s response letters were received.
Sept 2011
The safety and efficacy data were reviewed and found to comply with the relevant WHO
requirements.
Dec 2011
The company’s response letter was received.
Jan 2012
During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.
March 2012
The company’s response letters were received.
March 2012
During the meeting of the assessment team the additional quality data were reviewed and*Trade names are not prequalified by WHO. This is under local drug regulatory authority’s responsibility.
Throughout this WHOPAR the proprietary name is given as an example only.
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Artesunate 100mg+Mefloquine(as hydrochloride) 200 mg Tablets,(Cipla Ltd), MA079

May 2012
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II

WHOPAR part 7

December 2012

further information was requested.
During the meeting of the assessment team the additional quality data were reviewed andfurther information was requested.
The company’s response letter was received.
During the meeting of the assessment team the quality data were reviewed and further
information was requested.
The company’s response letter was received.
The quality data were reviewed and found to comply with the relevant WHO
requirements.
Product dossier accepted (quality assurance)
Artesunate/Mefloquine 100/200mg FDC (Fixed Dose Combination) Cipla Tablets wasincluded 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:
Cipla Limited,
A-42, MIDC,Patalganga, 410220
Dist: Raigad.
Maharashtra
India
Phone : (9122) 23082891
Fax: (9122) 23070013
E-mail: dsingh@cipla.com
Commitments for Prequalification
None.
Inspection status
The sites inspected were found to be compliant with WHO requirements for GMP and GLP.
For the sites not inspected, previous inspections either by a stringent regulatory authority or by WHO
showed acceptable outcome with respect to GMP, GLP and GCP.
2. (Advice on) conditions or restrictions regarding supply and use
Medicinal product subject to medical prescription.

Further information is available at:
http://www.who.int/prequal/

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