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The new suite will be used to produce non-sterile dosage forms, such as metered dose inhalers and semisolid topical products, for clinical studies up to Phase II.
CDMO Recipharm announced that it has opened a new GMP suite for the manufacture of clinical trial materials at its facility in Research Triangle Park, North Carolina, United States. Recipharm has invested $750k into the new suite, which will be used to produce non-sterile dosage forms, such as metered dose inhalers and semisolid topical products, for clinical studies up to Phase II. The new GMP suite is ISO 8 certified and includes a walk-in down-flow booth. The facility has the capacity to produce metered dose inhalers in up to 25-L batches and offers semisolid production capabilities up to 20 L.
With the GMP suite, Recipharm is now able to provide complete early development services from its facility in Research Triangle Park, including process development and scale-up, clinical trial materials manufacturing and packaging, product release, and stability programs. The development site in Research Triangle Park is part of the growing development services offered by Recipharm, from formulation development and analytical services, to clinical trial material manufacture.