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KDMF
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DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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Listed Suppliers
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
About the Company : Swati Spentose Pvt. Ltd. (SSPL), part of the 60-year-old V Group, is a globally trusted pharmaceutical manufacturer supplying to 70+ countries. We specialize in high-quality APIs a...
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Evonik
Evonik Health Care is the innovation hub for leading life science companies
Dosage Form : Orodispersible Tablet
Grade : Oral, Topical
Application : Disintegrants & Superdisintegrants
Excipient Details : Glycine is used as a disintegrant in solid dosage forms such as orally disintegrating tablets and in topical formulations such as emulsions & creams.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 75.07 g/mol
Ingredient(s) : Glycine Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Ophthalmic Solution
Grade : Biopharma Grade
Brand Name : Calcium Chloride Dihidrat...
Application : Parenteral
Excipient Details : Used as a buffering agent in liquid formulation like ophthalmics, parenterals, pharma/biopharma processes.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Calcium Chloride Dihidrato
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Brand Name : Dextrose Anhydrous
Application : Parenteral
Excipient Details : Used as an important carbon source for cell culture during upstream process. Use for vaccines, recombinant proteins, antibodies manufacturing.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : D Glucose Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Thickeners and Stabilizers
Excipient Details : Used as a chelating agent in cell culture media, downstream and as a chelator stabilizer in Biopharmaceutical formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Disodium Edetate Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Used as an ingredient in cell culture media in upstream, as a buffer elution in downstream and as a buffering agent in formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Glycine Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Brand Name : Magnesium Chloride Hexahy...
Application : Parenteral
Excipient Details : Used as a tonicity agent in cell culture in upstream process and injectable formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Magnesium Chloride Hexahydrate Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Brand Name : Potassium Chloride
Application : Parenteral
Excipient Details : Source of potassium and chloride in cell culture, also used as an osmotic regulator.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Potassium Chloride Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Brand Name : Sodium Bicarbonate
Application : Parenteral
Excipient Details : Used as a buffering agent in cell culture media, purification processes and injectable formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Sodium Bicarbonate Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Parenteral
Excipient Details : Used as an osmolarity agent in culture media, tonicity adjuster in ophthalmics and parenterals solutions.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Sodium Chloride Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Brand Name : Trisodium Citrate
Application : Parenteral
Excipient Details : Used as a buffering agent in purification process during downstream and in the final formulation.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Trisodium Citrate Excipient
High-quality raw materials and custom blends for pharma, biopharma, nutrition, veterinary, and cosmetics worldwide.
Dosage Form : Injectable / Parenteral
Grade : Biopharma Grade
Application : Surfactant & Foaming Agents
Excipient Details : Used as surfactant agent in cell culture media, in protein purification and in injectable formulations.
Pharmacopoeia Ref : On Request
Technical Specs : Low bacteria endotoxins, low bioburden (TAMC/TYMC). Customised packaging (from grs to kilograms)
Ingredient(s) : Polysorbate 80
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
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Solubilizers
API Stability Enhancers
Topical
Emulsifying Agents
Thickeners and Stabilizers
Surfactant & Foaming Agents
Fillers, Diluents & Binders
Film Formers & Plasticizers
Disintegrants & Superdisintegrants
Controlled & Modified Release
Direct Compression
Co-Processed Excipients
Rheology Modifiers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Regulatory FDF Prices
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FDF DOSSIERS
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REF. STANDARDS & IMPURITIES
EDQM
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
11
PharmaCompass offers a list of Dextrans API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dextrans manufacturer or Dextrans supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dextrans manufacturer or Dextrans supplier.
PharmaCompass also assists you with knowing the Dextrans API Price utilized in the formulation of products. Dextrans API Price is not always fixed or binding as the Dextrans Price is obtained through a variety of data sources. The Dextrans Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DEXTRAN POWDER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DEXTRAN POWDER, including repackagers and relabelers. The FDA regulates DEXTRAN POWDER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DEXTRAN POWDER API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of DEXTRAN POWDER manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DEXTRAN POWDER supplier is an individual or a company that provides DEXTRAN POWDER active pharmaceutical ingredient (API) or DEXTRAN POWDER finished formulations upon request. The DEXTRAN POWDER suppliers may include DEXTRAN POWDER API manufacturers, exporters, distributors and traders.
click here to find a list of DEXTRAN POWDER suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DEXTRAN POWDER DMF (Drug Master File) is a document detailing the whole manufacturing process of DEXTRAN POWDER active pharmaceutical ingredient (API) in detail. Different forms of DEXTRAN POWDER DMFs exist exist since differing nations have different regulations, such as DEXTRAN POWDER USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DEXTRAN POWDER DMF submitted to regulatory agencies in the US is known as a USDMF. DEXTRAN POWDER USDMF includes data on DEXTRAN POWDER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DEXTRAN POWDER USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DEXTRAN POWDER suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The DEXTRAN POWDER Drug Master File in Japan (DEXTRAN POWDER JDMF) empowers DEXTRAN POWDER API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the DEXTRAN POWDER JDMF during the approval evaluation for pharmaceutical products. At the time of DEXTRAN POWDER JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of DEXTRAN POWDER suppliers with JDMF on PharmaCompass.
A DEXTRAN POWDER CEP of the European Pharmacopoeia monograph is often referred to as a DEXTRAN POWDER Certificate of Suitability (COS). The purpose of a DEXTRAN POWDER CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DEXTRAN POWDER EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DEXTRAN POWDER to their clients by showing that a DEXTRAN POWDER CEP has been issued for it. The manufacturer submits a DEXTRAN POWDER CEP (COS) as part of the market authorization procedure, and it takes on the role of a DEXTRAN POWDER CEP holder for the record. Additionally, the data presented in the DEXTRAN POWDER CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DEXTRAN POWDER DMF.
A DEXTRAN POWDER CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DEXTRAN POWDER CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of DEXTRAN POWDER suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing DEXTRAN POWDER as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DEXTRAN POWDER API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture DEXTRAN POWDER as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain DEXTRAN POWDER and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DEXTRAN POWDER NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DEXTRAN POWDER suppliers with NDC on PharmaCompass.
DEXTRAN POWDER Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of DEXTRAN POWDER GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right DEXTRAN POWDER GMP manufacturer or DEXTRAN POWDER GMP API supplier for your needs.
A DEXTRAN POWDER CoA (Certificate of Analysis) is a formal document that attests to DEXTRAN POWDER's compliance with DEXTRAN POWDER specifications and serves as a tool for batch-level quality control.
DEXTRAN POWDER CoA mostly includes findings from lab analyses of a specific batch. For each DEXTRAN POWDER CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
DEXTRAN POWDER may be tested according to a variety of international standards, such as European Pharmacopoeia (DEXTRAN POWDER EP), DEXTRAN POWDER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DEXTRAN POWDER USP).
