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Will make materials for early phase clinical trials in new Raleigh-Durham site
February 9, 2016
By: Tim Wright
Editor-in-Chief, Contract Pharma
Contract development and manufacturing organization (CDMO) Cirrus Pharmaceuticals is set to launch its services for manufacturing cGMP materials for early phase clinical trials in its newly constructed state-of-the-art flexi-suite at its Raleigh-Durham, NC site in the U.S. “We are very excited about this new service offering to customers. Cirrus will be one of the few CDMOs with development and manufacturing capabilities for some of the niche dosage forms we have to offer. Specifically, we will be able to perform manufacturing for metered dose inhalers (MDI) on our Pamasol pressure filling line. The typical batch size offering is up to 25L and Cirrus will be able to perform one and two-step filling as well as cold filling for suspension and solution MDIs. Other than MDIs in the inhaled dosage forms, we will offer our clients dry powder filling in capsules for dry powder inhalers (DPI), and manufacture of nasal solutions, suspensions and powders,” said Andrew Hamer, vice president of R&D, Cirrus. “This new addition helps drive our goal to keep our customers competitive. We will now offer customers a seamless service from pre-formulation to clinical trial manufacturing in the U.S., and for oral solids and injectable products we can continue to offer commercial manufacturing from our plants in Sweden and India,” said Karan Bagaria, vice president of corporate development, Kemwell. Clinical manufacturing of other dosage forms that will be offered from the site are topicals (creams, ointments and gels), oral solids (tablets, capsules) and oral liquids.
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