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1. Gtpl7055
2. Q420394
3. [({[(2s,3r,4s,5r,6r)-4,5-bis({[(dihydroxyalumanyl)oxy]sulfonyl}oxy)-6-[({[(dihydroxyalumanyl)oxy]sulfonyl}oxy)methyl]-2-{[(2r,3s,4s,5r)-3,4,5-tris({[(dihydroxyalumanyl)oxy]sulfonyl}oxy)-2-[({[(dihydroxyalumanyl)oxy]sulfonyl}oxy)methyl]oxolan-2-yl]oxy}oxan-3-yl]oxy}sulfonyl)oxy]alumanediol
| Molecular Weight | 1464.8 g/mol |
|---|---|
| Molecular Formula | C11H44Al8O51S8 |
| Hydrogen Bond Donor Count | 16 |
| Hydrogen Bond Acceptor Count | 51 |
| Rotatable Bond Count | 36 |
| Exact Mass | 1463.713824 g/mol |
| Monoisotopic Mass | 1463.713824 g/mol |
| Topological Polar Surface Area | 532 Ų |
| Heavy Atom Count | 78 |
| Formal Charge | 0 |
| Complexity | 2400 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 9 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 17 |
| 1 of 2 | |
|---|---|
| Drug Name | Carafate |
| PubMed Health | Sucralfate (By mouth) |
| Drug Classes | Antiulcer, Protectant |
| Drug Label | CARAFATE Suspension contains sucralfate and sucralfate is an -D-glucopyranoside, -D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.CARAFATE Suspension for oral administration contains 1 g of sucralfate per 10 mL.CARAFATE Sus... |
| Active Ingredient | Sucralfate |
| Dosage Form | Tablet; Suspension |
| Route | Oral |
| Strength | 1gm/10ml; 1gm |
| Market Status | Prescription |
| Company | Forest Labs |
| 2 of 2 | |
|---|---|
| Drug Name | Carafate |
| PubMed Health | Sucralfate (By mouth) |
| Drug Classes | Antiulcer, Protectant |
| Drug Label | CARAFATE Suspension contains sucralfate and sucralfate is an -D-glucopyranoside, -D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.CARAFATE Suspension for oral administration contains 1 g of sucralfate per 10 mL.CARAFATE Sus... |
| Active Ingredient | Sucralfate |
| Dosage Form | Tablet; Suspension |
| Route | Oral |
| Strength | 1gm/10ml; 1gm |
| Market Status | Prescription |
| Company | Forest Labs |
API SUPPLIERS
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USDMF
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38867
Submission : 2023-09-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6108
Submission : 1985-10-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3542
Submission : 1979-06-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7282
Submission : 1988-01-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6048
Submission : 1985-09-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7160
Submission : 1987-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5825
Submission : 1985-05-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6331
Submission : 1985-10-25
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6057
Submission : 1985-09-05
Status : Inactive
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7186
Submission : 1987-11-03
Status : Inactive
Type : II
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Certificate Number : R0-CEP 2019-185 - Rev 01
Status : Valid
Issue Date : 2023-08-18
Type : Chemical
Substance Number : 1796
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DOSAGE - TABLET;ORAL - 1GM
USFDA APPLICATION NUMBER - 18333
DOSAGE - SUSPENSION;ORAL - 1GM/10ML
USFDA APPLICATION NUMBER - 19183
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sucralfate 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 Sucralfate manufacturer or Sucralfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sucralfate manufacturer or Sucralfate supplier.
PharmaCompass also assists you with knowing the Sucralfate API Price utilized in the formulation of products. Sucralfate API Price is not always fixed or binding as the Sucralfate Price is obtained through a variety of data sources. The Sucralfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sucralfatum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucralfatum, including repackagers and relabelers. The FDA regulates Sucralfatum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucralfatum 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 Sucralfatum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sucralfatum supplier is an individual or a company that provides Sucralfatum active pharmaceutical ingredient (API) or Sucralfatum finished formulations upon request. The Sucralfatum suppliers may include Sucralfatum API manufacturers, exporters, distributors and traders.
click here to find a list of Sucralfatum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sucralfatum DMF (Drug Master File) is a document detailing the whole manufacturing process of Sucralfatum active pharmaceutical ingredient (API) in detail. Different forms of Sucralfatum DMFs exist exist since differing nations have different regulations, such as Sucralfatum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sucralfatum DMF submitted to regulatory agencies in the US is known as a USDMF. Sucralfatum USDMF includes data on Sucralfatum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sucralfatum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sucralfatum 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 Sucralfatum Drug Master File in Japan (Sucralfatum JDMF) empowers Sucralfatum 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 Sucralfatum JDMF during the approval evaluation for pharmaceutical products. At the time of Sucralfatum 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 Sucralfatum suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Sucralfatum Drug Master File in Korea (Sucralfatum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sucralfatum. The MFDS reviews the Sucralfatum KDMF as part of the drug registration process and uses the information provided in the Sucralfatum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sucralfatum KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sucralfatum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sucralfatum suppliers with KDMF on PharmaCompass.
A Sucralfatum CEP of the European Pharmacopoeia monograph is often referred to as a Sucralfatum Certificate of Suitability (COS). The purpose of a Sucralfatum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sucralfatum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sucralfatum to their clients by showing that a Sucralfatum CEP has been issued for it. The manufacturer submits a Sucralfatum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sucralfatum CEP holder for the record. Additionally, the data presented in the Sucralfatum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sucralfatum DMF.
A Sucralfatum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sucralfatum 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 Sucralfatum suppliers with CEP (COS) on PharmaCompass.
A Sucralfatum written confirmation (Sucralfatum WC) is an official document issued by a regulatory agency to a Sucralfatum manufacturer, verifying that the manufacturing facility of a Sucralfatum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sucralfatum APIs or Sucralfatum finished pharmaceutical products to another nation, regulatory agencies frequently require a Sucralfatum WC (written confirmation) as part of the regulatory process.
click here to find a list of Sucralfatum 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 Sucralfatum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sucralfatum 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 Sucralfatum 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 Sucralfatum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sucralfatum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sucralfatum suppliers with NDC on PharmaCompass.
Sucralfatum 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 Sucralfatum 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 Sucralfatum GMP manufacturer or Sucralfatum GMP API supplier for your needs.
A Sucralfatum CoA (Certificate of Analysis) is a formal document that attests to Sucralfatum's compliance with Sucralfatum specifications and serves as a tool for batch-level quality control.
Sucralfatum CoA mostly includes findings from lab analyses of a specific batch. For each Sucralfatum 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.
Sucralfatum may be tested according to a variety of international standards, such as European Pharmacopoeia (Sucralfatum EP), Sucralfatum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sucralfatum USP).
