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Manufacturing The ability to move development stage inhalation products into first in man clinical studies is now a key step in accelerating the development process. To better serve these needs, Exemplar provides a state of the art cGMP clinical supplies manufacturing suite for pMDIs, DPIs, nasal and buccal sprays in support of Phase I through Phase IV activities. All processes are carried out in environmentally controlled rooms while formulation preparation and dispensing are performed under HEPA filtration using soft-wall, laminar flow clean room technologies.
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pMDI filling capabilities
- 30L to 200L Guisti pressure vessels
- Manual and semi-automatic Pamasol crimping and filling equipment
- Process development and scale-up support
DPI filling capabilities
- Based on the specific inhaler technology, Exemplar will work with the client to develop product and device specific filling processes
Aqueous nasal spray filling capabilities
- Semi-automatic filling processes for solution or suspension products
- Manual semi-automatic filling of single and bi-dose products
Labeling, packaging and assembly services
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Double blind pMDI and nasal spray masking devices Exemplar is the sole representative of Pharmask, Inc. (Medfield, Mass) for their unique line of double blind clinical masking devices. These devices will accommodate most commercial pMDI and nasal spray products. Once assembled, the masking devices do not interfere with the delivery performance of the test articles and cannot be dismantled without permanent damage. Exemplar provides double blind clinical masking and labeling services for these devices.
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Copyright © 2008 Exemplar Pharmaceuticals, LLC, a subsidiary of Exemplar Pharma, LLC. All rights reserved.
Exemplar Pharmaceuticals, LLC, 200 Riggenbach Rd, Fall River, MA USA 02720, Phone 508-676-6726, Fax 508-676-6546, Contact Exemplar via the Internet.
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