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Cytosol OEM

P.O. Box 1408, 1325 Wm. White Pl., NE
Lenoir, NC 28645 USA
Tel: 828/758-2343
Fax: 828/758-2345

E-mail: rclarke@cytosol.com

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Description:
Cytosol is CGMP compliant and NSAI ISO 9002/EN46002 certified. The company is FDA registered as a medical device and pharmaceutical manufacturer. It has no FDA 483 reports. The manufacturing infrastructure consists of Class 10,000 cleanroom assembly, Class 100 sterile solution filling suite, ERP software controlled inventory/production, experienced regulatory staff, and economic development zone for reduced costs. Sterilization capabilities include steam autoclave on-site, with gamma and EtO available nearby. Analytical services include a full chemical assay lab with HPLC capability on-site and a validated liquid and gel particle counter on-site. Experienced personnel have been manufacturing liquid pharmaceuticals and assembling medical devices for more than 17 years in the company's Lenoir, NC, facility.

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