Synopsis
Synopsis
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CEP/COS
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EU WC
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KDMF
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Europe
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US Medicaid
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Finished Drug Prices
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| Molecular Weight | 604.5 g/mol |
|---|---|
| Molecular Formula | C20H11N2Na3O10S3 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 2 |
| Exact Mass | 603.92689092 g/mol |
| Monoisotopic Mass | 603.92689092 g/mol |
| Topological Polar Surface Area | 238 A^2 |
| Heavy Atom Count | 38 |
| Formal Charge | 0 |
| Complexity | 1200 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 4 |
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ANALYTICAL
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ABOUT THIS PAGE
A Amaranth manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amaranth, including repackagers and relabelers. The FDA regulates Amaranth manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amaranth API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Amaranth supplier is an individual or a company that provides Amaranth active pharmaceutical ingredient (API) or Amaranth finished formulations upon request. The Amaranth suppliers may include Amaranth API manufacturers, exporters, distributors and traders.
click here to find a list of Amaranth suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amaranth DMF (Drug Master File) is a document detailing the whole manufacturing process of Amaranth active pharmaceutical ingredient (API) in detail. Different forms of Amaranth DMFs exist exist since differing nations have different regulations, such as Amaranth USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amaranth DMF submitted to regulatory agencies in the US is known as a USDMF. Amaranth USDMF includes data on Amaranth's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amaranth USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amaranth suppliers with USDMF on PharmaCompass.
Amaranth 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 Amaranth 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 Amaranth GMP manufacturer or Amaranth GMP API supplier for your needs.
A Amaranth CoA (Certificate of Analysis) is a formal document that attests to Amaranth's compliance with Amaranth specifications and serves as a tool for batch-level quality control.
Amaranth CoA mostly includes findings from lab analyses of a specific batch. For each Amaranth 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.
Amaranth may be tested according to a variety of international standards, such as European Pharmacopoeia (Amaranth EP), Amaranth JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amaranth USP).
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