Cirrus Pharmaceuticals, a Kemwell company, has announced it is ready 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, US site.
Cirrus R&D vice-president Andrew Hamer said: "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 MDls.
"Other than MDls 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."
Kemwell Corporate Development vice-president Karan Bagaria said: "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."
Clinical manufacturing of other dosage forms that will be offered from the site are topical, including creams, ointments and gels, and oral solids such as tablets and capsules, as well as oral liquids.