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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 |
API SUPPLIERS
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USDMF
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Prednisolone Sodium Phosphate, Process 2
Certificate Number : R1-CEP 2016-205 - Rev 01
Status : Valid
Issue Date : 2023-06-12
Type : Chemical
Substance Number : 735
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Certificate Number : R1-CEP 2011-149 - Rev 01
Status : Valid
Issue Date : 2022-02-15
Type : Chemical
Substance Number : 735
Certificate Number : CEP 2023-025 - Rev 00
Status : Valid
Issue Date : 2025-03-04
Type : Chemical
Substance Number : 735
Prednisolone Sodium Phosphate, Process C
Certificate Number : CEP 2023-402 - Rev 00
Status : Valid
Issue Date : 2024-04-11
Type : Chemical
Substance Number : 735
Certificate Number : R1-CEP 2016-329 - Rev 00
Status : Valid
Issue Date : 2023-07-13
Type : Chemical
Substance Number : 735
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Drugs in Development
Details:
Prednisolone Sodium Phosphate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Conjunctivitis, Allergic.
Lead Product(s): Prednisolone Sodium Phosphate,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 21, 2012
Lead Product(s) : Prednisolone Sodium Phosphate,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
Details : Prednisolone Sodium Phosphate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Conjunctivitis, Allergic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 21, 2012
Details:
Prednisolone Sodium Phosphate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Conjunctivitis, Allergic.
Lead Product(s): Prednisolone Sodium Phosphate,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 16, 2012
Lead Product(s) : Prednisolone Sodium Phosphate,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Prednisolone Sodium Phosphate is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Conjunctivitis, Allergic.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 16, 2012
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RLD : No
TE Code : AA
Brand Name : PREDNISOLONE SODIUM PHOSPHATE
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 25MG BASE/5ML
Approval Date : 2010-09-13
Application Number : 91396
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code : AA
Brand Name : PREDNISOLONE SODIUM PHOSPHATE
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 5MG BASE/5ML
Approval Date : 2004-05-25
Application Number : 75988
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
RLD : No
TE Code :
Brand Name : PREDNISOLONE SODIUM PHOSPHATE
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.9% PHOSPHATE
Approval Date : 1982-01-01
Application Number : 83358
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : PREDNISOLONE SODIUM PHOSPHATE
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 5MG BASE/5ML
Approval Date : 2003-03-26
Application Number : 75183
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
Brand Name : VASOCIDIN
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : EQ 0.23% PHOSPHATE;10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1988-08-26
Application Number : 18988
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AA
Brand Name : PREDNISOLONE SODIUM PHOSPHATE
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 15MG BASE/5ML
Approval Date : 2005-04-25
Application Number : 76913
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
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ABOUT THIS PAGE
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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prednisolone Sodium Phosphate manufacturer or Prednisolone Sodium Phosphate supplier.
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 Prednisolone Sodium Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prednisolone Sodium Phosphate, including repackagers and relabelers. The FDA regulates Prednisolone Sodium Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prednisolone Sodium Phosphate supplier is an individual or a company that provides Prednisolone Sodium Phosphate active pharmaceutical ingredient (API) or Prednisolone Sodium Phosphate finished formulations upon request. The Prednisolone Sodium Phosphate suppliers may include Prednisolone Sodium Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Prednisolone Sodium Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prednisolone Sodium Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Prednisolone Sodium Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Prednisolone Sodium Phosphate DMFs exist exist since differing nations have different regulations, such as Prednisolone Sodium Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prednisolone Sodium Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Prednisolone Sodium Phosphate USDMF includes data on Prednisolone Sodium Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prednisolone Sodium Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prednisolone Sodium Phosphate suppliers with USDMF on PharmaCompass.
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 Prednisolone Sodium Phosphate Drug Master File in Japan (Prednisolone Sodium Phosphate JDMF) empowers Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Prednisolone Sodium Phosphate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Prednisolone Sodium Phosphate suppliers with JDMF on PharmaCompass.
A Prednisolone Sodium Phosphate CEP of the European Pharmacopoeia monograph is often referred to as a Prednisolone Sodium Phosphate Certificate of Suitability (COS). The purpose of a Prednisolone Sodium Phosphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prednisolone Sodium Phosphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prednisolone Sodium Phosphate to their clients by showing that a Prednisolone Sodium Phosphate CEP has been issued for it. The manufacturer submits a Prednisolone Sodium Phosphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prednisolone Sodium Phosphate CEP holder for the record. Additionally, the data presented in the Prednisolone Sodium Phosphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prednisolone Sodium Phosphate DMF.
A Prednisolone Sodium Phosphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prednisolone Sodium Phosphate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Prednisolone Sodium Phosphate suppliers with CEP (COS) on PharmaCompass.
A Prednisolone Sodium Phosphate written confirmation (Prednisolone Sodium Phosphate WC) is an official document issued by a regulatory agency to a Prednisolone Sodium Phosphate manufacturer, verifying that the manufacturing facility of a Prednisolone Sodium Phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prednisolone Sodium Phosphate APIs or Prednisolone Sodium Phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Prednisolone Sodium Phosphate WC (written confirmation) as part of the regulatory process.
click here to find a list of Prednisolone Sodium Phosphate suppliers with Written Confirmation (WC) 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 Prednisolone Sodium Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prednisolone Sodium Phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prednisolone Sodium Phosphate suppliers with NDC on PharmaCompass.
Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate GMP manufacturer or Prednisolone Sodium Phosphate GMP API supplier for your needs.
A Prednisolone Sodium Phosphate CoA (Certificate of Analysis) is a formal document that attests to Prednisolone Sodium Phosphate's compliance with Prednisolone Sodium Phosphate specifications and serves as a tool for batch-level quality control.
Prednisolone Sodium Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Prednisolone Sodium Phosphate 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.
Prednisolone Sodium Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Prednisolone Sodium Phosphate EP), Prednisolone Sodium Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prednisolone Sodium Phosphate USP).
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