Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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NDC API
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VMF
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Listed Suppliers
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API
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FDF
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FDF Dossiers
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FDA Orange Book
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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EDQM
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USP
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JP
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Others
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
US Medicaid
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Annual Reports
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Finished Drug Prices
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| Molecular Weight | 1421.60 g/mol |
|---|---|
| Molecular Formula | C10H16K16N2O24P8 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 26 |
| Rotatable Bond Count | 11 |
| Exact Mass | 1421.2168179 g/mol |
| Monoisotopic Mass | 1419.2186991 g/mol |
| Topological Polar Surface Area | 512 Ų |
| Heavy Atom Count | 60 |
| Formal Charge | 0 |
| Complexity | 989 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 17 |
ABOUT THIS PAGE
A R915 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of R915, including repackagers and relabelers. The FDA regulates R915 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. R915 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 R915 supplier is an individual or a company that provides R915 active pharmaceutical ingredient (API) or R915 finished formulations upon request. The R915 suppliers may include R915 API manufacturers, exporters, distributors and traders.
click here to find a list of R915 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A R915 DMF (Drug Master File) is a document detailing the whole manufacturing process of R915 active pharmaceutical ingredient (API) in detail. Different forms of R915 DMFs exist exist since differing nations have different regulations, such as R915 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A R915 DMF submitted to regulatory agencies in the US is known as a USDMF. R915 USDMF includes data on R915's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The R915 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of R915 suppliers with USDMF on PharmaCompass.
R915 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 R915 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 R915 GMP manufacturer or R915 GMP API supplier for your needs.
A R915 CoA (Certificate of Analysis) is a formal document that attests to R915's compliance with R915 specifications and serves as a tool for batch-level quality control.
R915 CoA mostly includes findings from lab analyses of a specific batch. For each R915 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.
R915 may be tested according to a variety of international standards, such as European Pharmacopoeia (R915 EP), R915 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (R915 USP).
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