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Drug Approval Suppliers & Manufacturers

83 companies found

MedChemExpress LLC (MCE)

MedChemExpress LLC (MCE)

based inMonmouth Junction, NEW JERSEY (USA)
MedChemExpress (MCE) offers a wide range of high-quality research chemicals and biochemicals (novel life-science reagents, reference compounds and natural compounds) for scientific use. We have professionally experienced and friendly staff to meet ...
MedChemExpress - Model Tirabrutinib hydrochloride - 1439901-97-9

MedChemExpress - Model Tirabrutinib hydrochloride - 1439901-97-9

Tirabrutinib (ONO-4059) hydrochloride is an orally active Bruton’s Tyrosine Kinase (BTK) inhibitor (can cross the blood-brain barrier (BBB)), with an IC50 of 6.8 nM. Tirabrutinib hydrochloride irreversibly and covalently binds to BTK and inhibits ...
CONTACT SUPPLIER

International Drug Development Institute (IDDI)

International Drug Development Institute (IDDI)

based inLouvain-la-Neuve, BELGIUM
We are an expert clinical data services and high-level strategic consulting contract research organization (CRO), providing agile clinical trials services for pharmaceutical, biotech, and medical device/diagnostic companies. With a proven track ...
Clinical, Statistical and Regulatory Expert Services

Clinical, Statistical and Regulatory Expert Services

Aiming at optimizing your clinical development strategy, our expert consultants develop the innovative strategies and capabilities needed to launch products with the greatest potential for commercial success and improved patient outcomes. ...
CONTACT SUPPLIER

Catalent, Inc

Catalent, Inc

based inSomerset, NEW JERSEY (USA)
As the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world, we conduct all our business responsibly and with integrity. Our ...
GPEx - Cell Line Development Technology

GPEx - Cell Line Development Technology

GPEx cell line development technology is a proven technology that generates high-performance, highly stable, production cell lines. Virtually any cDNA (mAb and multigenic applications) can be inserted into cells. To date, over 600 different mAb ...
CONTACT SUPPLIER

Dyve Biosciences

Dyve Biosciences

based inThousand Oaks, CALIFORNIA (USA)
Dyve Biosciences created a breakthrough transdermal delivery platform that overturns the traditional limitations of administering therapies and allows for drug development across therapeutic areas. Our proprietary platform science can be applied to ...
Dyve - Breakthrough Transdermal Technology

Dyve - Breakthrough Transdermal Technology

The skin is the body’s natural protective layer, with two primary barriers to passage: the stratum corneum on the surface and restrictive junctional proteins deeper in the skin. The stratum corneum is composed of flattened corneocytes set ...
CONTACT SUPPLIER

Battelle Memorial Institute

Battelle Memorial Institute

based inColumbus, OHIO (USA)
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and ...
CONTACT SUPPLIER

Lung Therapeutics, Inc.

Lung Therapeutics, Inc.

based inAustin, TEXAS (USA)
Headquartered in Austin, Texas, Lung Therapeutics, Inc. is a clinical stage biopharmaceutical company formed to leverage decades of leading research in orphan, pulmonary indications for which there are unmet medical needs. The company is developing ...
Lung Therapeutics - Model LTI-01 - First-in-Class Treatment for Loculated Pleural Effusion (LPE)

Lung Therapeutics - Model LTI-01 - First-in-Class Treatment for Loculated Pleural Effusion (LPE)

A pleural effusion is defined by the build-up of fluid in the pleural cavity, predominantly resulting from pneumonia. A loculated pleural effusion (LPE) occurs when scar tissue forms in the pleural cavity, trapping the fluid and preventing ...
CONTACT SUPPLIER

Certara

Certara

based inPrinceton, NEW JERSEY (USA)
The drug discovery and development process is long and expensive with more failures than successes. At Certara, we anticipate and address your critical drug discovery and development risks and decisions using biosimulation, technology and services. ...
Simcyp - Biological Medicines Simulator

Simcyp - Biological Medicines Simulator

Biological medicines (“biologics” or “large molecule drugs”) now account for 30% of new drug approvals and up to 50% of the pharmaceutical industry’s pipeline. ...
CONTACT SUPPLIER

BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc.

based inNew Haven, CONNECTICUT (USA)
BioXcel Therapeutics, Inc. is a clinical-stage biopharmaceutical company utilizing artificial intelligence, or AI, approaches to develop transformative medicines in neuroscience and immuno-oncology. We are focused on utilizing cutting-edge ...
CONTACT SUPPLIER

Ascendia Pharmaceuticals

Ascendia Pharmaceuticals

based inNorth Brunswick, NEW JERSEY (USA)
Ascendia Pharmaceuticals specializes in the invention and development of specialty pharmaceutical products and novel formulation technologies. We provide formulation, analytical, and manufacturing services to pharmaceutical companies, working ...
505(b)(2) Product Development Services

505(b)(2) Product Development Services

A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today. The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a ...
CONTACT SUPPLIER

Taiwan Liposome Company, Ltd. (TLC)

Taiwan Liposome Company, Ltd. (TLC)

based inNangang Distric, TAIWAN
We are a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of best-in-class novel nanomedicines that combine our proprietary lipid-assembled drug delivery platform with approved active pharmaceutical ...
CONTACT SUPPLIER

ComplianceOnline

ComplianceOnline

based inSan Jose, CALIFORNIA (USA)
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous ...
CONTACT SUPPLIER

Advin Biotech, Inc.

Advin Biotech, Inc.

based in, CALIFORNIA (USA)
Founded by lateral-flow scientists in 2009, Advin Biotech, Inc. is an FDA registered purveyor of lateral-flow rapid diagnostics, specializing in the innovative design, structured development, and efficient manufacture of premium quality, ...
CONTACT SUPPLIER

Beldimed s.a.

Beldimed s.a.

based inAndrimont, BELGIUM
Created in 1986 under the name of “L’Agence Hendrick”, the company changed its name in 2017 when transferring its activities to the current facilities located in Andrimont (East of Belgium). In 2015, a joint venture, Ikris Pharma International, has ...
Named Patient Program

Named Patient Program

The expression “Patient First” is part of our DNA. We truly believe that every person in the world should have the same opportunities when it comes to healthcare because health is the ...
CONTACT SUPPLIER

Nautilus Biotechnology

Nautilus Biotechnology

based inSeattle, WASHINGTON (USA)
Nautilus (Nasdaq: NAUT) is a company with a vision to revolutionize biomedicine by unlocking the complexity of the human proteome. We are driven to transform the field of proteomics by democratizing access to the proteome and enabling fundamental ...
CONTACT SUPPLIER

Cellworks Research India Private Limited

Cellworks Research India Private Limited

based inBangalore, INDIA
Cellworks’ mission is to serve patients through advances in personalized medicine that significantly improve treatment success. We achieve better outcomes by predicting a successful match between patients and drug therapies – their Therapy Response ...
Precision Drug Development Services

Precision Drug Development Services

Accelerate drug development timelines, reduce risks and lower costs. Our biosimulation platform predicts human clinical response to investigational drug candidates YEARS earlier than traditional development ...
CONTACT SUPPLIER

EndoLogic LLC

EndoLogic LLC

based inClifton, NEW JERSEY (USA)
EndoLogic LLC is to design, develop, and market new patented technologies in the pharmaceutical and medical devices areas. EndoLogic has two divisions; the Pharmaceutical Division and the Medical Devices Division. Our Pharmaceutical Division focuses ...
EndoLogic - Model ATL-1251 - Renzapride

EndoLogic - Model ATL-1251 - Renzapride

Renzapride is best suited as a treatment of Diabetic Gastroparesis, a condition with a significant unmet treatment options. In the numerous trials that have been done using Renzapride more than 5000 patients have been treated with Renzapride. An ...
CONTACT SUPPLIER

UroGen Pharma, Inc.

UroGen Pharma, Inc.

based inPrinceton, NEW YORK (USA)
We are a biopharmaceutical company dedicated to building novel solutions that treat urothelial and specialty cancers. Our breakthrough therapy and innovative clinical pipeline aim to maximize the potential benefit of local delivery with our novel ...
UroGen - Model UGN-102 - Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

UroGen - Model UGN-102 - Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

UroGen is developing UGN-102 (mitomycin) for intravesical solution as a primary nonsurgical alternative to repetitive TURBT. UGN-102 is an investigational formulation that utilizes our innovative technology, RTGel™ reverse-thermal hydrogel, ...
CONTACT SUPPLIER

Auro Vaccines LLC

Auro Vaccines LLC

based inPearl River, NEW YORK (USA)
Auro Vaccines LLC is a clinical-stage vaccine development company pioneering a major evolutionary step in the design and development of preventive and therapeutic vaccines for infectious diseases. Our novel approach is based on a proprietary ...
VesiculoVax - Clinical-Stage Prophylactic Vaccines for Filoviruses

VesiculoVax - Clinical-Stage Prophylactic Vaccines for Filoviruses

Auro Vaccines has developed VesiculoVax™-vectored vaccines for pre- and post-exposure protection against the hemorrhagic disease caused by multiple species of filovirus (i.e. Zaire ebolavirus, Sudan ebolavirus and Marburg ...
CONTACT SUPPLIER

CureMatch, Inc.

CureMatch, Inc.

based inSan Diego, CALIFORNIA (USA)
CureMatch, Inc. is a San Diego-based digital health company focused on personalized medicine and combination therapy in oncology. CureMatch’s Decision Support System guides oncologists in the selection of cancer drugs that are customized for ...
Well-adapted Cancer Treatments Services

Well-adapted Cancer Treatments Services

The comprehensive analysis considers commonly used treatments, as well as targeted therapy, immunotherapy, hormone therapy, and newly approved oncology drugs. These options are presented either alone (monotherapy) ...
CONTACT SUPPLIER

Ascendia Pharmaceutical Solutions

Ascendia Pharmaceutical Solutions

based inNorth Brunswick, NEW JERSEY (USA)
Ascendia Pharmaceutical Solutions specializes in comprehensive drug development services, providing tailored formulation and manufacturing solutions from pre-formulation stages to commercialization. With a focus on overcoming pharmaceutical ...
Streamlined Development Service

Streamlined Development Service

In the intricate landscape of biopharmaceuticals, development timing is a critical factor that can significantly impact the success or failure of a drug. Saving time can mean the difference between being first to market for a new drug class or a ...
CONTACT SUPPLIER
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