Gastroenterology

Napo Pharmaceuticals produces crofelemer active pharmaceutical ingredient

Published in AIDS Weekly, December 18th, 2006

Napo Pharmaceuticals, Inc. announces the successful production of crofelemer active pharmaceutical ingredient (API) for use in a final pivotal Phase III trial for chronic diarrhea in people living with HIV/AIDS.

Napo is targeting approval of crofelemer for HIV/ AIDS (CRO-HIV) in 2008. The crofelemer API is manufactured by Glenmark Pharmaceuticals Ltd. at a dedicated unit at its U.S. Food & Drug Administration approved facility in Ankleshwar, India.

Glenmark is also the licensee of crofelemer from Napo for the indications of adult acute infectious diarrhea (CRO-ID), pediatric diarrhea (CRO-PED) and HIV/AIDS related diarrhea in approximately 140...

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Source: AIDS Weekly (2006-12-18)

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