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Capability

cGMP manufacturing

Suppliers
29
States & provinces
13
Countries
2

29 cgmp manufacturing suppliers across 13 states and provinces in 2 countries. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

FIDELIS ANIMAL HEALTH, INC.

NORTH BRUNSWICK, NJ

Fidelis Animal Health is a privately held, U.S.-based commercial stage company focused on acquiring, developing, and marketing unique pharmaceutical formulations for specialized veterinary needs. It uses its proprietary extended-release drug delivery technology, Fidelipid LAI, to provide long-lasting pain management solutions for laboratory and larger animals. Its lead product, Ethiqa XR, is commercialized and used throughout the U.S. Corporate headquarters are in New Jersey, with lead product manufactured in Pennsylvania under FDA-regulated cGMPs.

acquisition and marketing of pharmaceutical productsdrug delivery technologypharmaceutical formulation development

FUJIFILM Biosciences is a global life sciences and medical media provider and a world leader in the innovation, manufacturing, and distribution of cell culture media. It supplies ready-made and custom media solutions supporting biopharmaceutical, vaccine, and cell and gene therapy industries from small-scale prototyping to full commercial production, with GMP manufacturing facilities in California, Tokyo, and Tilburg.

bulk liquid manufacturingcell culture media manufacturingcustom media developmentmedia optimizationprocess liquids and buffer manufacturingtumble-blend dry powder media production

INTRALYTIX INC

COLUMBIA, MD

Intralytix, Inc. is a biotechnology company based in Columbia, Maryland, that develops bacteriophage-based products for food safety, dietary supplements, and human therapeutics. It pioneered the world's first phage-based FDA clearance for food safety (ListShield) in 2006 and holds FDA and USDA approvals for multiple phage food safety products. The company also runs clinical-stage phage therapy programs targeting antibiotic-resistant infections.

1,500L fermentationAI/ML-driven phage manufacturingbacteriophage discoveryclinical trialscommercial spray drying

IRVINE LABS INC

HUNTINGTON BEACH, CA

Irvine Labs is a Huntington Beach, California-based company established in 1997 that researches and develops natural, botanical drugs and supplements. It is a DEA bulk drug manufacturer, importer and exporter, and a cGMP manufacturer licensed by the FDA for food, supplements, and prescription and OTC drug manufacturing. Its drug candidates are in FDA clinical trials at Phase II or later.

botanical drug research and developmentbotanical extractionclinical trial material manufacturingcontract manufacturingDEA bulk drug manufacturing, importing and exportingGood Agricultural Practices (GAP) cultivation

KIMERA LABS INC

MIRAMAR, FL

Kimera Labs is an exosome biotechnology laboratory founded in 2012 by Duncan Ross, Ph.D., in Miramar, Florida. It produces perinatal mesenchymal stem cell (MSC)-derived exosome products for cosmetic and research purposes, operating from a 27,000 sq. ft. exosome-dedicated campus with ISO Class 5 hoods and ISO Class 7 cleanrooms and cGMP-compliant manufacturing.

AFMcell imagingdSTORM super-resolution microscopyELISAHPLCMSC exosome production and isolationNTARNA-seqRT-PCRTEMultracentrifugationWestern blot

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