Cirrus Pharmaceuticals, a Kemwell company, has announced that it is ready to launch its services for manufacturing cGMP materials for early phase clinical trials in its newly constructed flexi-suite at its Raleigh-Durham, USA site.
“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” says Andrew Hamer, Vice President of R&D at 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 US, and for oral solids and injectable products we can continue to offer commercial manufacturing from our plants in Sweden and India” says Karan Bagaria, VP of Corporate Development at 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.