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1. Pregna-1,4-diene-3,20-dione, 11,17-dihydroxy-21-(phosphonooxy)-, Disodium Salt, (11.beta.)-
2. Schembl1650407
3. Akos025394281
4. Ft-0631728
Molecular Weight | 484.4 g/mol |
---|---|
Molecular Formula | C21H27Na2O8P |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 3 |
Exact Mass | 484.12389338 g/mol |
Monoisotopic Mass | 484.12389338 g/mol |
Topological Polar Surface Area | 147 Ų |
Heavy Atom Count | 32 |
Formal Charge | 0 |
Complexity | 878 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 7 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
1 of 2 | |
---|---|
Drug Name | Prednisolone sodium phosphate |
Active Ingredient | Prednisolone sodium phosphate |
Dosage Form | Solution/drops; Tablet, orally disintegrating; Solution |
Route | Ophthalmic; Oral |
Strength | eq 15mg base/5ml; eq 5mg base/5ml; eq 25mg base/5ml; eq 15mg base; eq 10mg base/5ml; eq 20mg base/5ml; eq 30mg base; eq 0.9% phosphate; eq 10mg base |
Market Status | Prescription |
Company | Mylan Pharms; Amneal Pharms; Wockhardt; Pharm Assoc; Mission Pharma; Hi Tech Pharma; Paddock; Vintage; Bausch And Lomb |
2 of 2 | |
---|---|
Drug Name | Prednisolone sodium phosphate |
Active Ingredient | Prednisolone sodium phosphate |
Dosage Form | Solution/drops; Tablet, orally disintegrating; Solution |
Route | Ophthalmic; Oral |
Strength | eq 15mg base/5ml; eq 5mg base/5ml; eq 25mg base/5ml; eq 15mg base; eq 10mg base/5ml; eq 20mg base/5ml; eq 30mg base; eq 0.9% phosphate; eq 10mg base |
Market Status | Prescription |
Company | Mylan Pharms; Amneal Pharms; Wockhardt; Pharm Assoc; Mission Pharma; Hi Tech Pharma; Paddock; Vintage; Bausch And Lomb |
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PharmaCompass offers a list of Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate manufacturer or Prednisolone Sodium Phosphate supplier for your needs.
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PharmaCompass also assists you with knowing the Prednisolone Sodium Phosphate API Price utilized in the formulation of products. Prednisolone Sodium Phosphate API Price is not always fixed or binding as the Prednisolone Sodium Phosphate Price is obtained through a variety of data sources. The Prednisolone Sodium Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Inflamase Forte manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Inflamase Forte, including repackagers and relabelers. The FDA regulates Inflamase Forte manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Inflamase Forte API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Inflamase Forte supplier is an individual or a company that provides Inflamase Forte active pharmaceutical ingredient (API) or Inflamase Forte finished formulations upon request. The Inflamase Forte suppliers may include Inflamase Forte API manufacturers, exporters, distributors and traders.
click here to find a list of Inflamase Forte suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Inflamase Forte DMF (Drug Master File) is a document detailing the whole manufacturing process of Inflamase Forte active pharmaceutical ingredient (API) in detail. Different forms of Inflamase Forte DMFs exist exist since differing nations have different regulations, such as Inflamase Forte USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Inflamase Forte DMF submitted to regulatory agencies in the US is known as a USDMF. Inflamase Forte USDMF includes data on Inflamase Forte's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Inflamase Forte USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Inflamase Forte Drug Master File in Japan (Inflamase Forte JDMF) empowers Inflamase Forte 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 Inflamase Forte JDMF during the approval evaluation for pharmaceutical products. At the time of Inflamase Forte JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A Inflamase Forte CEP of the European Pharmacopoeia monograph is often referred to as a Inflamase Forte Certificate of Suitability (COS). The purpose of a Inflamase Forte CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Inflamase Forte EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Inflamase Forte to their clients by showing that a Inflamase Forte CEP has been issued for it. The manufacturer submits a Inflamase Forte CEP (COS) as part of the market authorization procedure, and it takes on the role of a Inflamase Forte CEP holder for the record. Additionally, the data presented in the Inflamase Forte CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Inflamase Forte DMF.
A Inflamase Forte CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Inflamase Forte CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Inflamase Forte written confirmation (Inflamase Forte WC) is an official document issued by a regulatory agency to a Inflamase Forte manufacturer, verifying that the manufacturing facility of a Inflamase Forte active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Inflamase Forte APIs or Inflamase Forte finished pharmaceutical products to another nation, regulatory agencies frequently require a Inflamase Forte WC (written confirmation) as part of the regulatory process.
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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 Inflamase Forte as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Inflamase Forte 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 Inflamase Forte 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 Inflamase Forte and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Inflamase Forte NDC to their finished compounded human drug products, they may choose to do so.
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Inflamase Forte 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 Inflamase Forte 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 Inflamase Forte GMP manufacturer or Inflamase Forte GMP API supplier for your needs.
A Inflamase Forte CoA (Certificate of Analysis) is a formal document that attests to Inflamase Forte's compliance with Inflamase Forte specifications and serves as a tool for batch-level quality control.
Inflamase Forte CoA mostly includes findings from lab analyses of a specific batch. For each Inflamase Forte 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.
Inflamase Forte may be tested according to a variety of international standards, such as European Pharmacopoeia (Inflamase Forte EP), Inflamase Forte JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Inflamase Forte USP).