Synopsis
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CEP/COS
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EU WC
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KDMF
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VMF
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EDQM
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JP
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Europe
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Australia
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South Africa
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DRUG PRODUCT COMPOSITIONS
US Medicaid
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Annual Reports
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
1. Schembl423029
Molecular Weight | 445.8 g/mol |
---|---|
Molecular Formula | C25H24FMgNO4 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 8 |
Exact Mass | 445.1539781 g/mol |
Monoisotopic Mass | 445.1539781 g/mol |
Topological Polar Surface Area | 90.6 Ų |
Heavy Atom Count | 32 |
Formal Charge | 0 |
Complexity | 631 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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PharmaCompass offers a list of Pitavastatin Magnesium 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 Pitavastatin Magnesium manufacturer or Pitavastatin Magnesium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pitavastatin Magnesium manufacturer or Pitavastatin Magnesium supplier.
PharmaCompass also assists you with knowing the Pitavastatin Magnesium API Price utilized in the formulation of products. Pitavastatin Magnesium API Price is not always fixed or binding as the Pitavastatin Magnesium Price is obtained through a variety of data sources. The Pitavastatin Magnesium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pitavastatin Magnesium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pitavastatin Magnesium, including repackagers and relabelers. The FDA regulates Pitavastatin Magnesium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pitavastatin Magnesium 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 Pitavastatin Magnesium supplier is an individual or a company that provides Pitavastatin Magnesium active pharmaceutical ingredient (API) or Pitavastatin Magnesium finished formulations upon request. The Pitavastatin Magnesium suppliers may include Pitavastatin Magnesium API manufacturers, exporters, distributors and traders.
click here to find a list of Pitavastatin Magnesium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pitavastatin Magnesium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pitavastatin Magnesium active pharmaceutical ingredient (API) in detail. Different forms of Pitavastatin Magnesium DMFs exist exist since differing nations have different regulations, such as Pitavastatin Magnesium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pitavastatin Magnesium DMF submitted to regulatory agencies in the US is known as a USDMF. Pitavastatin Magnesium USDMF includes data on Pitavastatin Magnesium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pitavastatin Magnesium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pitavastatin Magnesium 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 Pitavastatin Magnesium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pitavastatin Magnesium 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 Pitavastatin Magnesium 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 Pitavastatin Magnesium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pitavastatin Magnesium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pitavastatin Magnesium suppliers with NDC on PharmaCompass.
Pitavastatin Magnesium 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 Pitavastatin Magnesium 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 Pitavastatin Magnesium GMP manufacturer or Pitavastatin Magnesium GMP API supplier for your needs.
A Pitavastatin Magnesium CoA (Certificate of Analysis) is a formal document that attests to Pitavastatin Magnesium's compliance with Pitavastatin Magnesium specifications and serves as a tool for batch-level quality control.
Pitavastatin Magnesium CoA mostly includes findings from lab analyses of a specific batch. For each Pitavastatin Magnesium 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.
Pitavastatin Magnesium may be tested according to a variety of international standards, such as European Pharmacopoeia (Pitavastatin Magnesium EP), Pitavastatin Magnesium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pitavastatin Magnesium USP).