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