Synopsis
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USDMF
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CEP/COS
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KDMF
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VMF
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FDF
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FDA Orange Book
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Europe
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
US Medicaid
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Annual Reports
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Finished Drug Prices
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API SUPPLIERS
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EU WC
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API Imports and Exports
INTERMEDIATE SUPPLIERS
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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
Rochem International Inc
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical
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
Application : Taste Masking
Excipient Details : CM90 is a directly compressible, granulated calcium carbonate with maltodextrin used for swallow tablets due to its high density and compressibility.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 490- 500, Tapped Density: 1.50
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Direct Compression
Excipient Details : DC SIM 100 is a directly compressible simethicone powder used for antacid and anti-gas tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : Vitasmooth is a directly compressible calcium carbonate, preformulated with excipients used for the production of chewable or antacid meltaway tablets
Pharmacopoeia Ref : NA
Technical Specs : Tapped Density: 0.80, PSD D50: 153
Ingredient(s) : Calcium Carbonate Excipient
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seqens
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]PMC Isochem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
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 : Gel
Grade : Parenteral, Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Application : Parenteral
Excipient Details : Castor oil is used as an oily solvent in parenteral dosage forms.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical
Application : Topical
Excipient Details : Octyldodecanol is used as a solvent in topical dosage forms.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
Application : Solubilizers
Excipient Details : Poloxamer 188 is used as a solubilizer, emulsifier, stabilizer in parenteral, OSDs & topical formulations such as creams, gels & lotions.
Pharmacopoeia Ref : ChP/USP/EP
Technical Specs : Oxyethylene unit: 75%-85%, Oxypropylene unit: 25%-30%
Ingredient(s) : Poloxamer 188
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Topical, Oral
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment
Grade : Parenteral, Oral, Topical
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Oral
Application : Solubilizers
Excipient Details : Polysorbate 40 is used as a wetting and solubilizing agent in various topical and oral formulations.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral, Topical
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]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
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]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lubrizol Life Science Health
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shandong Focus Biotechnology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Coating Systems & Additives
Solubilizers
Emulsifying Agents
Thickeners and Stabilizers
Film Formers & Plasticizers
Controlled & Modified Release
Parenteral
Fillers, Diluents & Binders
Surfactant & Foaming Agents
Direct Compression
Granulation
Lubricants & Glidants
Co-Processed Excipients
API Stability Enhancers
Taste Masking
Rheology Modifiers
Empty Capsules
Chewable & Orodispersible Aids
Vegetarian Capsules
Coloring Agents
Disintegrants & Superdisintegrants
Digital Content
DATA COMPILATION #PharmaFlow
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Hyamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyamine, including repackagers and relabelers. The FDA regulates Hyamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyamine 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 Hyamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyamine supplier is an individual or a company that provides Hyamine active pharmaceutical ingredient (API) or Hyamine finished formulations upon request. The Hyamine suppliers may include Hyamine API manufacturers, exporters, distributors and traders.
click here to find a list of Hyamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Hyamine Drug Master File in Japan (Hyamine JDMF) empowers Hyamine 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 Hyamine JDMF during the approval evaluation for pharmaceutical products. At the time of Hyamine 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 Hyamine suppliers with JDMF on PharmaCompass.
A Hyamine written confirmation (Hyamine WC) is an official document issued by a regulatory agency to a Hyamine manufacturer, verifying that the manufacturing facility of a Hyamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Hyamine APIs or Hyamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Hyamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Hyamine suppliers with Written Confirmation (WC) 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 Hyamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hyamine 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 Hyamine 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 Hyamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hyamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hyamine suppliers with NDC on PharmaCompass.
Hyamine 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 Hyamine 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 Hyamine GMP manufacturer or Hyamine GMP API supplier for your needs.
A Hyamine CoA (Certificate of Analysis) is a formal document that attests to Hyamine's compliance with Hyamine specifications and serves as a tool for batch-level quality control.
Hyamine CoA mostly includes findings from lab analyses of a specific batch. For each Hyamine 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.
Hyamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Hyamine EP), Hyamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hyamine USP).
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