Supply Chain Management

Product Description

  • GMP Compliant Storage of a wide range of client products from API and excipients to consumables as well as both Stability and Retention sample programs.
  • Facility and Staff certified for storage, handling, and shipment of hazardous materials. Including Flammable, Toxic, Potent, etc. products.
  • Environmental conditions ranging from Controlled-Room Temperature (15-25°C) to Deep Frozen (-80°C).
  • US (Bloomington, IN) and European (Switzerland and Italy) Locations.
  • Clinical Distribution for bulk stock and just in time resupply. IWRS/IVRS integration ready and labeling, relabeling, and kitting services offered.
  • Commercial 3PL management/distribution/transportation

Singota Solutions

  • US
  • 2017
    On CPHI since
  • 3
    Certificates
  • 50 - 99
    Employees
Company types
CMO/CDMO
Primary activities
Analytical Services
Biopharmaceutical
Chemical Development
Clinical Research
Packaging & drug delivery
Packaging materials
Regulatory Affairs
Supply Chain
Transport/Logistics/Distribution
Specifications
  • Selling Points
    Quality Service; Leading CDMO whose unparalleled expertise in drug development, manufacturing, and supply chain solutions (Domestic & International) empowers you to navigate the complexities of the drug development process with confidence. Discover how our tailored strategies and comprehensive services can help you close gaps, minimize line loss, and develop products poised for successful clinical trials.
  • Supplied from
    United States

Singota Solutions

  • US
  • 2017
    On CPHI since
  • 3
    Certificates
  • 50 - 99
    Employees
Company types
CMO/CDMO
Primary activities
Analytical Services
Biopharmaceutical
Chemical Development
Clinical Research
Packaging & drug delivery
Packaging materials
Regulatory Affairs
Supply Chain
Transport/Logistics/Distribution

More Products from Singota Solutions (11)

  • Singota Solutions Overview

    Product Singota Solutions Overview

    Overview of Singota Solutions capabilities
  • Aseptic Filling

    Product Aseptic Filling

    We specialize in producing small volume batches with a focus on tailored solutions, minimized line loss, and reduced lead times. 

    Singota's robotic aseptic filling service is supported by utilizing the latest technology - a Cytiva (formerly Vanrx) SA25 robotic workcell, featuring a complete...
  • Formulation Development

    Product Formulation Development

    Singota solutions offers wide range of services which includes analytical and formulation development. We create a robust method for analysis of product, whether starting from scratch or optimizing a method, and can help create a set of solutions that are customized to you, while supporting that metho...
  • GMP Analytical Testing

    Product GMP Analytical Testing

    Singota solutions offers wide range of services which includes GMP analytical testing.
    Studies & Methodologies: • Material Identity • In Process • Product Release • Product Specific Assays • Compendial • Microbial (Endotoxin, Bioburden, Sterility) • CoA Generation • ICH Stability (All ICH...
  • Kitting/Labeling Services

    Product Kitting/Labeling Services

    Singota Solutions offers wide range of services which includes kitting, and labeling. We customize kitting for preclinical and clinical trials, can design kitting for single and double blind studies, and any customized solutions needed. Once completed, we can ship directly to the clinical trial site or oth...
  • Packaging service

    Product Packaging service

    Singota solutions offers wide range of services which includes packaging. It customize packaging solutions with the options of single, double, or multi cell cartons or cases. Packaging can also be performed for temperature sensitive materials with tor tracking. Contact us for more information.
  • Pre-formulation & formulation development

    Product Pre-formulation & formulation development

    Singota solutions offers wide range of services which includes pre-formulation & formulation development. It is suitable for pre-clinical and clinical use. It deliver pre-formulation, excipient and formulation studies of parenteral, oral, ocular, topical, and lyophilized formulations. Solubility, ph, degra...
  • Process development

    Product Process development

    Singota solutions offers wide range of services which includes process development. It provide process development solutions, as a product moves through the clinical trial process into commercial manufacturing environments, manufacturing scale and processes can change. It can ensures to prepare for the pos...
  • Raw material testing

    Product Raw material testing

    Singota solutions offers wide range of services which includes raw material testing. Contact us for more information.
  • Stability test programs

    Product Stability test programs

    Singota solutions offers wide range of services which includes stability test programs. Contact us for more information.
  • Supply Chain and Materials Management

    Product Supply Chain and Materials Management

    Singota manages a wide range of materials from APIs and excipients to finished products. We have the capability to handle toxic, potent, flammable, and hazardous materials. Our secure, cGMP warehouse offers storage conditions including controlled room temperature (15-25°C), 2-8°C, -20°C, and -80°C. Sin...

Singota Solutions resources (1)

Frequently Viewed Together

  • Product Biosimilars Portfolio

    • Pegfilgrastim (Filed with EMA) • Filgrastim (Filed with EMA) • Trastuzumab (Filed with EMA, MHRA, Received recommendation for marketing authorization in India) • Bevacizumab (Filed with MHRA) • Omalizumab (Global PhIII ongoing) • Denosumab (Global PhIII ongoing) • Ranibizumab (Global PhIII ongoing...
  • Product Biotest Human Serum Albumin

    • Human Serum Albumin for the biotechnology and pharmaceutical industry • We offer a human serum albumin (HSA) product that complies with the regulatory requirements of multiple health authorities.   • It is manufactured in a GMP compliant, state-of-the-art manufacturing plant and supplied und...
  • Product UV Light Blocking Tyvek Equipment Covers

    UV Light Blocking Tyvek Equipment Covers are designed to keep cleaned pharmaceutical equipment and supplies clean and protected from external sources of contamination while also providing in-process protection to light sensitive biotech products.
  • Product Biologic drug substance CDMO services

    From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
  • Product GMP Liquid Buffer & Custom Liquid Blends

    Actylis manufactures buffers, process solutions, cleaning solutions, Water for Injection (WFI) for further processing, and custom liquid blends in complinace with Good Manufacturing Practices in our new state-of-the-art GMP liquid processing facility in Ireland.

    Actylis has seven manufacturing facil...
  • Product WHEATON Roller Apparatus by DWK

    WHEATON® roller apparatus are used for roller bottle cell culture, an established cell culture method and relatively inexpensive way to set up a flexible and scaleable biopharmaceutical operation. In addition to the standard product DWK also offer a wide range of customized options to accommodate the most ...
  • Product RoSS® Shell: Protection of single-use bags

    Protect your single-use bioprocess containers: RoSS® Shells - abbreviated for Robust Storage and Shipping - reduce product loss towards 0%. Compatible with all available sizes and types of single-use bags, RoSS enables standardized and scalable end-to-end process solutions for fluid management and col...
  • Product Sodium Hydroxide Solution

    Sodium hydroxide compendial grade pellets blended with USP purified water. Can be packaged in drums or totes.
  • Product Hyatrue® — Pharmaceutical Grade Sodium Hyaluronate

    Hyatrue® is a pharmaceutical grade sodium hyaluronate which can be used as an API or excipient for drugs and medical devices in ophthalmic preparations, intra-articular injections, anti-adhesive preparations, topical preparations for wound healing and soft tissue filler, etc. Hyatrue® sodium hyaluronate ...
  • Product Fermentation

    Relying on an experience gained over more than 50 years, OLON represent one of the most extensive know how of microbial fermentation in Europe. The Group, global leader in biomanufacturing, has two Biotechnology Centres located in Italy and is one of the first companies in Italy producing via microbial ...
  • Product ULC Series 328

    FARRAR® pioneered forced air convection cooling to answer the challenge of preserving and storing biological and human tissue donor samples and materials. Purpose-built for life science applications, the Ultra-Low Chamber ULC-190, ULC-259, and ULC-328 are the only -20°C to-80°C, forced air, ultra-low-t...
  • Product Biochemicals, Biomolecules and Salts

    At Advancion, we consistently deliver products through a traceable and auditable supply chain of high-quality fine chemicals tailored to help you successfully move your products from pilot to commercial-scale production. Choose with confidence from our selection of product offerings incl...
  • Product Custom Protein Synthesis

    We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
  • Product Aprotinin

    DADELI is a GMP-certified pharmaceutical manufacturer for intermediates,APIs and finished formulations.Our main APIs include HCG,Aprotinin(Currently in China we are the only one to produce Aprotinin complying with the latest EP 11.0), Oxymatrine,Isoniazidum,Egg Lecithin,Daidzein,etc.Warmly welcome all cust...
  • Product Urobilinogen code A1536

    https://www.itwreagents.com/iberia/en/product/urobilinogen/A1536
  • Product Sterility Test Isolator

    1. Built-in Vaporized Hydrogen Peroxide (VHPS) generator for bio-decontamination which can reach 6-log Sterility Assurance Level

    2. The VHPS residual concentration is less than 1ppm after aeration

    3. leakage rate is less than 0.5% /vol/hour under 2 times working pressure test
    qq...
  • Product Ultimus® Film

    An innovative single-use film offering strength and leak resistance for your toughest liquid bioprocessing applications. Ultimus® film provides enhanced bag strength, improved durability and leak resistance through a novel strength layer reinforced by woven nylon. The inert fluid contact layer promotes hea...
  • Product Bioprocessing solutions and excipients for protein therapeutic formulations

    From excipients for protein therapeutic formulations, to innovating solutions for bioprocessing, we have decades of experience in protein delivery. TALK TO US about our latest launches: Virodex™ detergent range, a sustainable alternative to Triton™ X-100 for viral inactivation and cell lysis. Plus, Tween...
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    With our advanced gene technology and proprietary cell line, we are able to overcome common bottlenecks that come with developing high-performance mammalian cell lines, especially when expressing novel molecule types.

    Mammalian cells are the gold standard for biologics development. 

    ...
  • Product Sterile Grade at ISO Class 5 facility

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  • Product Naf Spray

    Fluorine prophylaxis of the dental caries.

    DOSAGEfrom 2 to 4 years: 0,50 mg per day (2 puffs).from 4 years and in adults: 1mg per day (4 puffs).1 puff contains 0,25mg of Fluorine ions (F-).

    INGREDIENTSFluorine + Xylitol (Sodium Fluoride and Xylitol).

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  • Product Innovation Hub_Pharma Virtual Lab by Roquette

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  • Product FPFs

    • Genexol®PM Inj.(Paclitaxel)   • Genexol® Inj.(Paclitaxel) • Nanoxel®M Inj.(Docetaxel) • Docetaxel Inj.(Docetaxel) • Nexatin® Inj.(Oxaliplatin) • Everose® Tab.(Everolimus) • Pemed®S Inj.(Pemetrexed) • Azalid® Inj.(Azacitidine) • Decilid® Inj.(Decitabine) • Lenalid® Inj.(Lenalid...
  • Product Technology Transfer

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    Manufacturing of plasmid DNA as starting material for:

    • Clinical manufacturing of gene and immuno-oncology therapies, for example in AAV or lentiviral vector.
    • Clinical manufacturing of biological drugs.

    Quality Highlights:
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  • Product DWRX1010 (Colonoscopy Bowel Preparation Drug)

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  • Product Biotech Development

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    The Carten BPV series offers unique advantages over traditional single use valves ,pinch valves or alternatives, through ensuring an operator friendly product that minimises changeover times between batches. When a new tubing size is required, there is no costly new valve purchase required as within normal...
  • Product HANQUYOU(trastuzumab)

    HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) was successfully launched in the U.S., China and Europe, becoming the Chinese mAb biosimilar entering the U.S., the EU and China market. It is indicated for the treatment of HER2 positive early breast cancer, metastatic bre...
  • Product Semaglutide API

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    Complete quality documents:...
  • Product Gx RTF® ClearJect® Polymer syringes

    Gx RTF® ClearJect® syringes are made from COP (Cyclo Olefin Polymer). They are glue-free as the cannula is not glued in, but is instead insert-molded during the injection molding process, no aggregation due to metal or tungsten residues, high viscosity silicone oil for reduced particles, minimal extractabl...
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  • Product Antide

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  • Product Eye drop Grade Sodium Hyaluronate (Hyaluronic Acid )

    Eye-drop Grade Sodium Hyaluronate has GMP certification in China and the status of API registration status is A. It has the advantages of ultra-low impurity level, ultra-low endotoxin level, ultra-low metal impurity residue and ultra-low microbial pollution.
    • M...
  • Product Drug Substance Manufacturing - Mammalian Cell Cultures

    • Around 430,000 L total commercial capacity for cell culture  • Manufacturing sites around the globe: Biberach/Germany, Vienna/Austria, Fremont, CA/USA and Shanghai/ China- from 2,000 up to 15,000 L bioreactors  • GMP facilities licensed by EMA, FDA, MHLW and other authorities ...
  • Product Safe and cost-efficient packaging of pharmaceutical products

    After introducing a new medication to the market, it is always a challenge for pharmaceutical manufacturers to calculate production capacities without incurring economic losses. With support from machine manufacturer Schubert-Pharma and packaging specialist Faller Packaging, manufacturers now have two stro...
  • Product Protein or Biologics Higher Order Structure Analysis

    We provide higher-order structure analysis to drive insight into the secondary and tertiary structures of protein in “normal “presentation as well as a function of temperature and pH, allowing the study of subtle structure changes that may occur during processing, storage or handling as well as protein agg...
  • Product Icatibant

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  • Product Tannic acid

    Name: Tannic Acid

    Alias: Tannins

    CAS #1401-55-4Molecular Formula: C76H52O
    Appearance:Light brown irregular powder


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    Our hoses for pharma biotech, cosmetics, food, beverage and chemical industry 

    We offer you a wide range of hoses specially designed for the pharmaceutical, biotech, cosmetic, food, beverage and chemical industries. We also ensure their proper use through training in the co...
  • Product BioHale® Sucrose

    BioHale® Sucrose is a non-reducing crystalline disaccharide made up of glucose and fructose. Sucrose is commonly used in the biopharmaceutical industry to stabilize proteins, lipids, and carbohydrates during the formulation process. The utility and function is driven by its unique chemical and physical pro...
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    CAS NO::126-11-4Appearance::White To Almost White Powder
    Molecular Formula::C4H9NO5
    Molecular Weight::151.12
    EINECS NO::204-769-5
    MDL NO::MFCD00007395
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    When you know the biopharma solution you need and want to find the perfect delivery partner, Caldic has the expertise to source, process and customize packaging to your exact requirements. From packaging and single use solutions to stainless steel vials, and following allergen, GMO or REACH regulatory requ...
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    H2BioCat is an enzyme on carbon biocatalyst system for highly selective chemical synthesis via hydrogen-driven cofactor supply to any NADH/Flavin dependent redox enzyme
    • 100% atom efficient cofactor recycling: mitigates waste from typical carbon based reductants for biocatalysis (glucose / alcohol) ...
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    Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO). Our six state-of-the-art cGMP manufacturing facilities across Asia and North America deliver to more than 100 markets around the world. Our sites have the highest industry standards for quality, dev...