Artesunate/Amodiaquine 50 mg/135 mg Tablets(Ipca Laboratories Ltd), MA081

WHOPAR part 7

October 2021

Steps before prequalificationI.

BACKGROUND INFORMATION ON THE PROCEDURE

1. Submission of the dossier
The company Ipca Laboratories Ltd submitted in 2010 an application for [MA081 trade name] * (MA081) tobe assessed with the aim of including [MA081 trade name] in the list of prequalified medicinal products forthe treatment of malaria.
[MA081 trade name] was assessed according to the ‘Procedure for Assessing the Acceptability, in Principle,of Pharmaceutical Products for Purchase by United Nations Agencies’ by the team of WHO assessors. Theassessors are senior experts, mainly from national authorities, invited by WHO to participate in theprequalification assessment process.
2. Steps taken in the evaluation of the product
July 2010
Aug 2010
Sept 2010
Nov 2010
Dec 2010
Jan 2011
June 2011
July 2011
Sept 2011
Nov 2011
Jan 2012
Jan 2012
Feb 2012
March2012
March2012
March2012
March
2012
April 2012
May 2012
May 2012
May 2012
01 June2012*

During the meeting of the assessment team the safety and efficacy data and the quality data
were reviewed and further information was requested.
The company’s response letter was received.
During the meeting of the assessment team the efficacy data were reviewed and furtherinformation was requested.
The company’s response letter was received.
The manufacturer of one of the APIs was inspected for compliance with WHO requirements
for GMP.
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 additional efficacy data were reviewed andfurther information 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 efficacy data the additional quality
data were reviewed and further information was requested.
The company’s response letter was received.
The manufacturer of one of the APIs was inspected for compliance with WHO requirements
for GMP.
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 manufacturer of the FPP was inspected for compliance with WHO requirements for GMP.
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).
[MA081 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.

Artesunate/Amodiaquine 50 mg/135 mg Tablets(Ipca Laboratories Ltd), MA081

WHOPAR part 7

II.

GENERAL CONDITIONS FOR THE PREQUALIFICATION

1.

Manufacture, Commitments and Inspection status

October 2021

Manufacture of the finished product and responsible for batch release
Ipca Laboratories Ltd
Plot No. 255/1
Village Athal
396 230 Silvassa
Dadra and Nagar Haveli
India
Tel: 0260 6164200/6164203
Inspection status
The sites inspected were found to be in compliance with WHO requirements for GMP.
Not inspected for GCP. Previous site inspections by WHO showed acceptable outcome.
2.

(Advice on) Conditions or restrictions regarding supply and useMedicinal product subject to medical prescription.
Further information is available at:https://extranet.who.int/pqweb/medicines/prequalified-lists/finished-pharmaceutical-products