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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
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-05
Pay. Date : 2024-07-03
DMF Number : 40145
Submission : 2024-07-04
Status : Active
Type : II
NDC Package Code : 54469-0010
Start Marketing Date : 2023-11-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-05
Pay. Date : 2015-12-18
DMF Number : 30056
Submission : 2016-02-03
Status : Active
Type : II
Certificate Number : R0-CEP 2019-185 - Rev 01
Issue Date : 2023-08-18
Type : Chemical
Substance Number : 1796
Status : Valid
NDC Package Code : 69984-001
Start Marketing Date : 2016-01-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2019-04-22
Registration Number : 20190211-211-J-310(2)
Manufacturer Name : Zhejiang Haisen Pharmaceutical Co., Ltd
Manufacturer Address : Xiangtan Village, Liushi Street, Dongyang City, Zhejiang Province, China.
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-04-02
Pay. Date : 2025-01-22
DMF Number : 41032
Submission : 2024-12-25
Status : Active
Type : II
NDC Package Code : 31260-401
Start Marketing Date : 2025-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3542
Submission : 1979-06-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-18
Pay. Date : 2014-04-09
DMF Number : 16589
Submission : 2003-05-13
Status : Active
Type : II
NDC Package Code : 55512-0020
Start Marketing Date : 2014-01-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7552
Submission : 1988-06-21
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 : 6048
Submission : 1985-09-27
Status : Inactive
Type : II
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USDMF
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 : 7552
Submission : 1988-06-21
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 : 7186
Submission : 1987-11-03
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6057
Submission : 1985-09-05
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
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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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EUROAPI
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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 Sucralfato manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucralfato, including repackagers and relabelers. The FDA regulates Sucralfato manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucralfato 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 Sucralfato manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sucralfato supplier is an individual or a company that provides Sucralfato active pharmaceutical ingredient (API) or Sucralfato finished formulations upon request. The Sucralfato suppliers may include Sucralfato API manufacturers, exporters, distributors and traders.
click here to find a list of Sucralfato suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sucralfato DMF (Drug Master File) is a document detailing the whole manufacturing process of Sucralfato active pharmaceutical ingredient (API) in detail. Different forms of Sucralfato DMFs exist exist since differing nations have different regulations, such as Sucralfato USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sucralfato DMF submitted to regulatory agencies in the US is known as a USDMF. Sucralfato USDMF includes data on Sucralfato's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sucralfato USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sucralfato 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 Sucralfato Drug Master File in Japan (Sucralfato JDMF) empowers Sucralfato 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 Sucralfato JDMF during the approval evaluation for pharmaceutical products. At the time of Sucralfato 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 Sucralfato 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 Sucralfato Drug Master File in Korea (Sucralfato KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sucralfato. The MFDS reviews the Sucralfato KDMF as part of the drug registration process and uses the information provided in the Sucralfato KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sucralfato 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 Sucralfato API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sucralfato suppliers with KDMF on PharmaCompass.
A Sucralfato CEP of the European Pharmacopoeia monograph is often referred to as a Sucralfato Certificate of Suitability (COS). The purpose of a Sucralfato CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sucralfato EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sucralfato to their clients by showing that a Sucralfato CEP has been issued for it. The manufacturer submits a Sucralfato CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sucralfato CEP holder for the record. Additionally, the data presented in the Sucralfato CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sucralfato DMF.
A Sucralfato CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sucralfato 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 Sucralfato suppliers with CEP (COS) on PharmaCompass.
A Sucralfato written confirmation (Sucralfato WC) is an official document issued by a regulatory agency to a Sucralfato manufacturer, verifying that the manufacturing facility of a Sucralfato active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sucralfato APIs or Sucralfato finished pharmaceutical products to another nation, regulatory agencies frequently require a Sucralfato WC (written confirmation) as part of the regulatory process.
click here to find a list of Sucralfato 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 Sucralfato as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sucralfato 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 Sucralfato 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 Sucralfato and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sucralfato NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sucralfato suppliers with NDC on PharmaCompass.
Sucralfato 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 Sucralfato 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 Sucralfato GMP manufacturer or Sucralfato GMP API supplier for your needs.
A Sucralfato CoA (Certificate of Analysis) is a formal document that attests to Sucralfato's compliance with Sucralfato specifications and serves as a tool for batch-level quality control.
Sucralfato CoA mostly includes findings from lab analyses of a specific batch. For each Sucralfato 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.
Sucralfato may be tested according to a variety of international standards, such as European Pharmacopoeia (Sucralfato EP), Sucralfato JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sucralfato USP).
