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Jaguar Health Achieves Key Milestone for Crofelemer API Manufacturer

Supports the expansion of manufacturing volume required for potential additional indications for crofelemer.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Jaguar Health, Inc. has successfully completed the registration of the source of the active pharmaceutical ingredient (API) of crofelemer with the Agenzia Italiana Del Farmaco (AIFA), the Italian Medicines Agency. As a result, batches of crofelemer API manufactured by Milan, Italy-based Indena S.P.A. can now be used by Jaguar for further development work.
 
“We are very pleased about the completion of this key milestone in the ongoing process of establishing Indena as an additional approved crofelemer manufacturer as we work to support the increased crofelemer manufacturing demand expected upon potential FDA approval of crofelemer for new indications, including approval for cancer therapy-related diarrhea (CTD),” said David Sesin, Ph.D., Jaguar’s chief manufacturing officer. “Jaguar is honored to have had a long-standing relationship with Indena, a pioneer and world-class leader in plant-based pharmaceutical manufacturing.”

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