HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
Cipla committed to scale-up production of Lopinavir/Ritonavir (LPVr) pellets to 30,000 bottles per month in 2018 and to submitting the new “4-in-1” (ABC/3TC/LPV/r) pellets in 2018.
Cipla
Sub-Actions & Milestones
Develop 4-in-1 granules and submit to FDA in 2018
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Granules under development. Expectation to file dossier with FDA in with BE data in Q3 and clinical data in December 2018
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Submit the new “4-in-1” (ABC/3TC/LPV/r) pellets in 2018.
Cipla
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Scale-up production of Lopinavir/Ritonavir (LPVr) pellets to 30,000 bottles per month in 2018
Cipla
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Submit request to FDA for new process (change of solvent) to enable 2.5x greater production capacity
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Request filed and approved. Moving to scale up production to 60,000/month
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Updates
Notes
Responsible