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Drug Application Equipment Supplied In North America
49 equipment items found
Manufactured by:SIGA Technologies, Inc. based inNew York, NEW YORK (USA)
SIGA completed clinical trials for the IV formulation with funding from the Biomedical Advanced Research and Development Authority (BARDA). In April 2021, SIGA submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for IV TPOXX®. It was formally approved by FDA in May 2022. ...
Manufactured by:Rebiotix Inc., a Ferring Company based inRoseville, MINNESOTA (USA)
Rebiotix Inc., a Ferring Company, has conducted several trials of the lead microbiota-based product in the MRT drug platform, RBX2660, for reducing the rate of recurrence of Clostridioides difficile infection. RBX2660 is currently under study in a Phase 3 clinical trial in conjunction with the US Food and Drug Administration’s Investigational New ...
by:Curemark based inRye Brook, NEW YORK (USA)
Centers for Disease Control and Prevention estimate that 1 in 68 children in the United States have been diagnosed with Autism. There is currently no approved drug on the market that treats the core symptoms of Autism. At Curemark, we are working to change that. Curemark’s lead drug candidate, CM-AT, has received “Fast Track” designation from ...
Manufactured by:Jericho Sciences, LLC based inDurham (RTP), NORTH CAROLINA (USA)
Jericho is developing a new therapeutic drug for FIV infection in cats, working toward a New Animal Drug Application (NADA) with the FDA. Our ongoing studies indicate that Jericho’s small molecule drug candidate can reduce FIV virus levels in chronically-infected cats for many months in the absence of continuing treatment. ...
Manufactured by:Tonix Pharmaceuticals Holding Corp. based inChatham, NEW JERSEY (USA)
TNX-1300 (recombinant T172R/G173Q double-mutant cocaine esterase 200 mg, IV solution) is being developed under an Investigational New Drug application (IND) for the treatment of cocaine intoxication. It has been designated a Breakthrough Therapy by the FDA. Currently there is no specific pharmacotherapy indicated for cocaine intoxication, a state characterized by ...
Manufactured by:Cabaletta Bio, Inc. based inPhiladelphia, PENNSYLVANIA (USA)
DSG3-CAART is designed to selectively target and kill the B cells that produce DSG3 antibodies while preserving the healthy B cells critical to immune function. In September 2019, the FDA cleared our investigational new drug application for our clinical study of DSG3-CAART in patients with mucosal pemphigus vulgaris. We received Orphan Drug ...
Manufactured by:Tekni-Plex based inWayne, PENNSYLVANIA (USA)
CELLENE™ MC1053 is a high clarity, nontoxic, halogen and phthalate free, flexible thermoplastic elastomer compound developed specifically for extrusion applications in the food and medical industries. All components used in the manufacturing of CELLENE™ MC1053 are sanctioned by the US Food & Drug Administration for food ...
Manufactured by:RoosterBio, Inc. based inFrederick, MARYLAND (USA)
RoosterCollect™-EV-CC is a standardized chemically defined, and low particulate collection medium for scalable and streamlined extracellular vesicle (EV) collection. RoosterCollect-EV-CC is one component of RoosterBio’s CliniControl™ EV Production System – a bioprocess engine for rapid EV manufacturing for use in cGMP and clinical applications. Each bag of ...
Manufactured by:G-CON Manufacturing, Inc. based inCollege Station, TEXAS (USA)
megaPOD consists of high bay POD units for oversized equipment. Ballroom configurations are available. RECOMMENDED FOR Any medicinal drug or medical device application (upstream/ downstream processing, formulation, filling, packaging, gene/viral vector ...
Manufactured by:NP Medical Inc. based inClinton, MASSACHUSETTS (USA)
The Pressure Activated Valve is used extensively as a "one-way" valve in critical drug delivery applications, and as an "anti-siphon" valve in pump applications. It targets patient applications requiring very specific performance characteristics such as high-pressure rating and narrow specification ranges for key attributes. ...
Manufactured by:Suvoda based inConshohocken, PENNSYLVANIA (USA)
Overcome the traditional challenges of electronic outcomes data collection and submission for complex clinical ...
Manufactured by:Alfa Chemistry based inNY, NEW YORK (USA)
Introducing fluorine atom(s) into bioactive organic compounds has become a leading strategy for drug design and lead optimization. In drug synthesis strategy, fluorine is frequently employed to modify biologically relevant properties such as metabolic stability, basicity, lipophilicity and bioavailability. Additionally, the binding affinity of compounds to biological targets may also improve upon ...
Manufactured by:Biopharma PEG Scientific Inc based inWatertown, MASSACHUSETTS (USA)
Uses: Applicated in medical research, drug-release, nanotechnology and new materials research, cell culture. In the study of ligand, polypeptide synthesis support, a graft polymer compounds, new materials, and polyethylene glycol-modified functional coatings and other aspects of the active ...
Manufactured by:BioXcel Therapeutics, Inc. based inNew Haven, CONNECTICUT (USA)
BXCL501 is our most advanced neuroscience clinical program. BXCL501 is a proprietary, sublingual film formulation of dexmedetomidine, a selective alpha-2 receptor agonist. It is being investigated for at-home use for the acute treatment of agitation in bipolar and schizophrenia patients, for agitation in Alzheimer’s disease, and as an adjunctive treatment for major depressive ...
Manufactured by:Biopharma PEG Scientific Inc based inWatertown, MASSACHUSETTS (USA)
Uses: Applicated in medical research, drug-release, nanotechnology and new materials research, cell culture. In the study of ligand, polypeptide synthesis support, a graft polymer compounds, new materials, and polyethylene glycol-modified functional coatings and other aspects of the active compound. ...
Manufactured by:Cingulate based inKansas City, KANSAS (USA)
CTx-1302 utilizes a breakthrough multi-core formulation of dextroamphetamine, a compound approved by the FDA for the treatment of ...
Manufactured by:G-CON Manufacturing, Inc. based inCollege Station, TEXAS (USA)
The POD System integrates multiple connected units to accommodate larger footprint installations with suites, airlocks, and corridors. RECOMMENDED FOR Any medicinal drug or medical device application (upstream/ downstream processing, formulation, filling, packaging, gene/viral vector ...
Manufactured by:InSphero AG based inSchlieren, SWITZERLAND
When you’re ready, we deliver. InSphero assay-ready spheroid microtissues are engineered and certified for use in critical drug development applications, and validated to ensure uniform size, robust functionality, and reproducible results. We develop 3D InSight™ Microtissues using the most advanced 3D cell culture technologies available to produce ...
Manufactured by:Allevi, Inc. based inPhiladelphia, PENNSYLVANIA (USA)
Clinically relevant drug-drug interactions (DDI) are a serious concern for any new drug development project. To better support capturing the multiple mechanisms of DDI potential using primary hepatocytes, we now offer Interaction Qualified Human Hepatocytes (Catalog HUCPI) which are characterized for 3 major mechanisms of DDI: transporter activity, enzyme activity, and induction potential, ...
Manufactured by:Elixir Medical Corporation based inMilpitas, CALIFORNIA (USA)
Novolimus is a metabolite of the drug Sirolimus, a novel mTOR inhibitor macrolytic lactone with anti-proliferative and anti-inflammatory properties developed by Elixir Medical. The macrocyclic lactone drugs represent the most widely utilized drug family for drug-eluting stent applications and have an established ...