New Delhi, Oct 4: Drug firm Cipla on Thursday said an anti-malarial drug developed by Drugs for Neglected Diseases initiative (DNDi) has received pre-qualification from the World Health Organisation (WHO).
The Mumbai-headquartered firm is manufacturing the fixed dose combination drug of Artesunate and Mefloquine (ASMQ FDC) under a technology transfer agreement with Neglected Diseases initiative (DNDi).
This Cipla-manufactured ASMQ FDC is the first artesunate-mefloquine FDC to be prequalified by WHO and is recommended for the treatment of malaria, Cipla said in a statement.
'Pre-qualification' is a process under which drug companies have to fulfil certain WHO-stipulated conditions to become eligible to supply vaccines to UN procurement agencies globally.
"The prequalification announcement is recognition that ASMQ FDC meets WHO`s high quality standards and we aim to make this treatment widely available throughout Asia," Cipla Medical Director Jaideep Gogtay said.
ASMQ FDC was originally developed by DNDi and the Brazilian government-owned pharmaceutical company Farmanguinhos/Fiocruz and was registered in Brazil in 2008.
A technology transfer between Farmanguinhos and Cipla was achieved in 2010 to facilitate the implementation of ASMQ FDC in Asia.
The combination of AS and MQ is one of five Artemisinin Combination Therapies (ACTs) currently recommended by WHO for the treatment of uncomplicated P falciparum malaria, and is the first-line treatment in a number of South East Asian countries.
"The availability of ASMQ FDC will have a direct impact on patients, especially in Asia," DNDi Executive Director Bernard Pecoul said.
ASMQ FDC was registered in India in 2011 and in Malaysia in early 2012. In India, about 18,000 adult patients have already been treated with this combination.
The ASMQ FDC is manufactured in Cipla's Patalganga facility, which is approved by WHO-Geneva, US FDA, MHRA-UK and various other regulatory bodies.
A prequalified status makes ASMQ FDC eligible to tenders that receive funding from international procurement agencies, such as UNICEF and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
Shares of Cipla on Thursday closed at Rs 381.10 on the BSE, up 0.24 per cent from its previous close.
