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Speed to Market was key to Intercept Pharmaceuticals' Ocaliva Launch

High-speed bulk bottling line helped Intercept Pharmaceuticals bring its orphan drug to the U.S. market.

Ocaliva tablets for commercial distribution in the U.S. are packed on Almac’s high-speed bulk fill bottling line in its U.S. commercial packaging facility in Audubon, PA.
Ocaliva tablets for commercial distribution in the U.S. are packed on Almac’s high-speed bulk fill bottling line in its U.S. commercial packaging facility in Audubon, PA.

[Editor's note: This is an updated version of this story, which was initially published online July 19, 2016]

U.S. patients suffering with primary biliary cholangitis now can treat the chronic liver disease with Ocaliva™ (obeticholic acid), developed as a result of a partnership between biopharmaceutical firm Intercept Pharmaceuticals, Inc. and the Almac Group, a global contract development and manufacturing organization.

Ocaliva is classified as a pharmaceutical product, and was reviewed and approved by the U.S. FDA’s Center for Drug Evaluation and Research. It is considered an orphan drug, a designation the agency gives to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S.

Ocaliva tablets for commercial distribution in the U.S. are packed on Almac’s high-speed bulk fill bottling line in its U.S. commercial packaging facility in Audubon, PA. The bottling line can fill tablets and capsules and uses electronic filling systems with in-line sensors to confirm fill count accuracy, labeling and component code and print verification. Ocaliva tablets are packed 30/bottle for commercial distribution. For commercial distribution in the EU, Ocaliva tablets are planned for packaging at Almac’s U.K. commercial packaging facility in Craigavon, UK.
“Intercept chose Almac to partner with on this project as they could offer multiple services from bulk drug product manufacture to local packaging in both the E.U. and US markets,” says Richard Lancaster, Intercept Pharma’s Senior Director, Product Development.

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