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Cryoport's MVE Biological Solutions Registers All Manufacturing Facilities with the U.S. Food and Drug Administration ("FDA")
All Three MVE Biological Solutions' Manufacturing Facilities Are Registered With the FDA and All Applicable MVE Products Are Now Listed NASHVILLE, Tenn., Jan.
About this update from Cryoport, Inc.
[{"type":"text","content":"All Three MVE Biological Solutions' Manufacturing Facilities Are Registered With the FDA and All Applicable MVE Products Are Now Listed\nNASHVILLE, Tenn., Jan. 6, 2025 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX), a global leader in supply chain solutions for the life sciences industry, today announced that MVE Biological Solutions (\"MVE\"), a Cryoport company and the leading global manufacturer of high-quality cryogenic freezers and dewars, has officially registered all three of its manufacturing facilities (located in Ball Ground, Georgia; New Prague, Minnesota; and Chengdu, China) with the U.S. Food and Drug Administration (\"FDA\"). Additionally, all applicable MVE-manufactured cryogenic freezers and dewars are now listed with the FDA.\n\n \n \n \n \n \n \n\n \nTo meet the standards of FDA-registered facilities, MVE adheres to stringent requirements, including but not limited to 21 CFR Part 820 and Good Manufacturing Practices (\"GMP\"). This FDA registration and product listing is in addition to MVE's existing ISO 13485 certification.\n\"MVE's achievement underscores our commitment to delivering the highest-quality and most reliable supply chain solutions for the life sciences industry,\" said Jerrell Shelton, CEO, Cryoport. \"Our MVE team's dedication to serving our clients' needs and bringing lifesaving therapies to patients is consistent with the high standards we practice in all business units companywide. This FDA registration reflects MVE's commitment to excellence by meeting the strictest of global regulatory standards.\"\nCryoport clients, customers and/or partners who wish to verify MVE's registration may do so through the FDA's database or by contacting the Company at [email protected].\nAbout Cryoport, Inc.\nCryoport, Inc. (Nasdaq: CYRX), is a global leader in supply chain solutions for cell & gene therapies that enable manufacturers, contract development manufacturers (CDMOs), contract research organizations (CROs), developers, and researchers to carry out their respective business with certainty. We provide a broad array of supply chain solutions for the life sciences industry. Through our platform of critical products and solutions, which include advanced temperature-controlled packaging, informatics, specialized bio-logistics services, bio-storage, bio-services, and cryogenic systems, we are \"...