Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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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
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1. Ft-0659154
Molecular Weight | 1112.1 g/mol |
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Molecular Formula | C54H56Cl2N8O10S2 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 16 |
Rotatable Bond Count | 15 |
Exact Mass | 1110.2937877 g/mol |
Monoisotopic Mass | 1110.2937877 g/mol |
Topological Polar Surface Area | 300 Ų |
Heavy Atom Count | 76 |
Formal Charge | 0 |
Complexity | 893 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 6 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
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ABOUT THIS PAGE
A Cloxacillin Benzathine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cloxacillin Benzathine, including repackagers and relabelers. The FDA regulates Cloxacillin Benzathine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cloxacillin Benzathine 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 Cloxacillin Benzathine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cloxacillin Benzathine supplier is an individual or a company that provides Cloxacillin Benzathine active pharmaceutical ingredient (API) or Cloxacillin Benzathine finished formulations upon request. The Cloxacillin Benzathine suppliers may include Cloxacillin Benzathine API manufacturers, exporters, distributors and traders.
click here to find a list of Cloxacillin Benzathine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cloxacillin Benzathine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cloxacillin Benzathine active pharmaceutical ingredient (API) in detail. Different forms of Cloxacillin Benzathine DMFs exist exist since differing nations have different regulations, such as Cloxacillin Benzathine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cloxacillin Benzathine DMF submitted to regulatory agencies in the US is known as a USDMF. Cloxacillin Benzathine USDMF includes data on Cloxacillin Benzathine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cloxacillin Benzathine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cloxacillin Benzathine suppliers with USDMF 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 Cloxacillin Benzathine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cloxacillin Benzathine 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 Cloxacillin Benzathine 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 Cloxacillin Benzathine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cloxacillin Benzathine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cloxacillin Benzathine suppliers with NDC on PharmaCompass.
Cloxacillin Benzathine 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 Cloxacillin Benzathine 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 Cloxacillin Benzathine GMP manufacturer or Cloxacillin Benzathine GMP API supplier for your needs.
A Cloxacillin Benzathine CoA (Certificate of Analysis) is a formal document that attests to Cloxacillin Benzathine's compliance with Cloxacillin Benzathine specifications and serves as a tool for batch-level quality control.
Cloxacillin Benzathine CoA mostly includes findings from lab analyses of a specific batch. For each Cloxacillin Benzathine 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.
Cloxacillin Benzathine may be tested according to a variety of international standards, such as European Pharmacopoeia (Cloxacillin Benzathine EP), Cloxacillin Benzathine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cloxacillin Benzathine USP).
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