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DRUG PRODUCT COMPOSITIONS0
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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.
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
Date of Issue : 2022-08-05
Valid Till : 2025-10-21
Written Confirmation Number : WC-0454
Address of the Firm :
NDC Package Code : 84142-001
Start Marketing Date : 2019-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
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 : 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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 11876
Submission : 1996-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7552
Submission : 1988-06-21
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Certificate Number : R0-CEP 2019-185 - Rev 01
Status : Valid
Issue Date : 2023-08-18
Type : Chemical
Substance Number : 1796
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Japanese Pharmacopoeia Sucralfate Hydrate
Registration Number : 218MF10954
Registrant's Address : 5850-1 Higashine-cho, Higashine City, Yamagata Prefecture
Initial Date of Registration : 2006-11-24
Latest Date of Registration : 2006-11-24
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Registrant Name : Korea Pavise Pharmaceutical Co., Ltd.
Registration Date : 2019-06-25
Registration Number : 20190625-211-J-370
Manufacturer Name : Elementis Pharma GmbH
Manufacturer Address : Giulinistr. 2 67065 Ludwigshafen Germany
Registrant Name : Intro Biopharma Co., Ltd.
Registration Date : 2019-04-03
Registration Number : 20190211-211-J-310(1)
Manufacturer Name : Zhejiang Haisen Pharmaceutic...
Manufacturer Address : Xiangtan Village, Liushi Street, Dongyang City, Zhejiang Province, China.
Registrant Name : Sechang International Co., Ltd.
Registration Date : 2019-02-11
Registration Number : 20190211-211-J-310
Manufacturer Name : Zhejiang Haisen Pharmaceutic...
Manufacturer Address : Xiangtan Village, Liushi Street, Dongyang City, Zhejiang Province, China.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2019-04-22
Registration Number : 20190211-211-J-310(2)
Manufacturer Name : Zhejiang Haisen Pharmaceutic...
Manufacturer Address : Xiangtan Village, Liushi Street, Dongyang City, Zhejiang Province, China.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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FDF Dossiers
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Sucralfin
Dosage Form : Sucralfate 1.000Mg 40 Combined Oral Use
Dosage Strength : 40 CPR 1 g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Sucralfin
Dosage Form : Sucralfate 2.000Mg 30 Joined' Oral Use
Dosage Strength : os grat 30 bust 2 g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : SUCRALFIN
Dosage Form : Sachets
Dosage Strength : 2g
Packaging : 30 UNITS 2000 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : SUCRALFIN
Dosage Form : Tablet
Dosage Strength : 1g
Packaging : 40 UNITS 1000 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : RX
Registration Country : USA
Brand Name : CARAFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Packaging :
Approval Date : 1982-01-01
Application Number : 18333
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : CARAFATE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 1GM/10ML
Packaging :
Approval Date : 1993-12-16
Application Number : 19183
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : SULCRATE SUSPENSION PLUS
Dosage Form : SUSPENSION
Dosage Strength : 1G/5ML
Packaging :
Approval Date :
Application Number : 2103567
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : SULCRATE
Dosage Form : TABLET
Dosage Strength : 1G
Packaging :
Approval Date :
Application Number : 2100622
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Sweden
Brand Name : Andapsin
Dosage Form : ORAL SUSPENSION IN SACHET
Dosage Strength : 1 G / 5 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Antepsin
Dosage Form : Antic-calc Tablet
Dosage Strength : 1 g
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : Yes
TE Code : AB
Brand Name : CARAFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 1982-01-01
Application Number : 18333
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : CARAFATE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 1GM/10ML
Approval Date : 1993-12-16
Application Number : 19183
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : SUCRALFATE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 1GM/10ML
Approval Date : 2024-05-21
Application Number : 216474
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : SUCRALFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 2022-04-15
Application Number : 215576
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : SUCRALFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1GM
Approval Date : 1998-06-08
Application Number : 74415
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : SUCRALFATE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 1GM/10ML
Approval Date : 2025-04-14
Application Number : 211780
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : SUCRALFATE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 1GM/10ML
Approval Date : 2022-03-15
Application Number : 211884
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Sucralfin
Dosage Form : Sucralfate 1.000Mg 40 Combined Oral Use
Dosage Strength : 40 CPR 1 g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Sucralfin
Dosage Form : Sucralfate 2.000Mg 30 Joined' Oral Use
Dosage Strength : os grat 30 bust 2 g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : SUCRALFIN
Dosage Form : Sachets
Dosage Strength : 2g
Packaging : 30 UNITS 2000 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : SUCRALFIN
Dosage Form : Tablet
Dosage Strength : 1g
Packaging : 40 UNITS 1000 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Andapsin
Dosage Form : ORAL SUSPENSION IN SACHET
Dosage Strength : 1 G / 5 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Andapsin
Dosage Form : ORAL SUSPENSION
Dosage Strength : 200 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Andapsin
Dosage Form : TABLET
Dosage Strength : 1 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Antepsin
Dosage Form : Antic-calc Tablet
Dosage Strength : 1 g
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Antepsin
Dosage Form : Antic-calc Tablet
Dosage Strength : 1 g
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Antepsin
Dosage Form : Potion, suspension
Dosage Strength : 200 mg/ml
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : SULCRATE SUSPENSION PLUS
Dosage Form : SUSPENSION
Dosage Strength : 1G/5ML
Packaging :
Approval Date :
Application Number : 2103567
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : SULCRATE
Dosage Form : TABLET
Dosage Strength : 1G
Packaging :
Approval Date :
Application Number : 2100622
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : APO-SUCRALFATE - TAB 1G
Dosage Form : TABLET
Dosage Strength : 1G
Packaging : 100'S,500'S,620'S,700'S
Approval Date :
Application Number : 2125250
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PMS-SUCRALFATE
Dosage Form : TABLET
Dosage Strength : 1000MG
Packaging : 100/500
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : TEVA-SUCRALFATE
Dosage Form : TABLET
Dosage Strength : 1G
Packaging : 100/500
Approval Date :
Application Number : 2045702
Regulatory Info : Prescription
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 1GM
USFDA APPLICATION NUMBER - 18333
DOSAGE - SUSPENSION;ORAL - 1GM/10ML
USFDA APPLICATION NUMBER - 19183
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Dosage Form : Tablet
Grade : Oral
Brand Name : Magnesium Stearate
Application : Lubricants & Glidants
Excipient Details : Magnesium stearate is the magnesium salt of stearic acid. It acts as a lubricating agent and stabilizer in tablet manufacturing.
Dosage Form : Capsule
Grade : Oral
Brand Name : Microcrystalline Cellulos...
Application : Fillers, Diluents & Binders
Excipient Details : Microcrystalline cellulose has excellent compressibility and it is used as fillers, diluents & binders in various oral solid formulations such as tablets and capsules.
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
ABOUT THIS PAGE
16
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 Sucraxol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucraxol, including repackagers and relabelers. The FDA regulates Sucraxol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucraxol 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 Sucraxol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sucraxol supplier is an individual or a company that provides Sucraxol active pharmaceutical ingredient (API) or Sucraxol finished formulations upon request. The Sucraxol suppliers may include Sucraxol API manufacturers, exporters, distributors and traders.
click here to find a list of Sucraxol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sucraxol DMF (Drug Master File) is a document detailing the whole manufacturing process of Sucraxol active pharmaceutical ingredient (API) in detail. Different forms of Sucraxol DMFs exist exist since differing nations have different regulations, such as Sucraxol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sucraxol DMF submitted to regulatory agencies in the US is known as a USDMF. Sucraxol USDMF includes data on Sucraxol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sucraxol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sucraxol 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 Sucraxol Drug Master File in Japan (Sucraxol JDMF) empowers Sucraxol 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 Sucraxol JDMF during the approval evaluation for pharmaceutical products. At the time of Sucraxol 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 Sucraxol 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 Sucraxol Drug Master File in Korea (Sucraxol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sucraxol. The MFDS reviews the Sucraxol KDMF as part of the drug registration process and uses the information provided in the Sucraxol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sucraxol 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 Sucraxol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sucraxol suppliers with KDMF on PharmaCompass.
A Sucraxol CEP of the European Pharmacopoeia monograph is often referred to as a Sucraxol Certificate of Suitability (COS). The purpose of a Sucraxol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sucraxol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sucraxol to their clients by showing that a Sucraxol CEP has been issued for it. The manufacturer submits a Sucraxol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sucraxol CEP holder for the record. Additionally, the data presented in the Sucraxol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sucraxol DMF.
A Sucraxol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sucraxol 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 Sucraxol suppliers with CEP (COS) on PharmaCompass.
A Sucraxol written confirmation (Sucraxol WC) is an official document issued by a regulatory agency to a Sucraxol manufacturer, verifying that the manufacturing facility of a Sucraxol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sucraxol APIs or Sucraxol finished pharmaceutical products to another nation, regulatory agencies frequently require a Sucraxol WC (written confirmation) as part of the regulatory process.
click here to find a list of Sucraxol 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 Sucraxol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sucraxol 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 Sucraxol 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 Sucraxol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sucraxol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sucraxol suppliers with NDC on PharmaCompass.
Sucraxol 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 Sucraxol 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 Sucraxol GMP manufacturer or Sucraxol GMP API supplier for your needs.
A Sucraxol CoA (Certificate of Analysis) is a formal document that attests to Sucraxol's compliance with Sucraxol specifications and serves as a tool for batch-level quality control.
Sucraxol CoA mostly includes findings from lab analyses of a specific batch. For each Sucraxol 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.
Sucraxol may be tested according to a variety of international standards, such as European Pharmacopoeia (Sucraxol EP), Sucraxol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sucraxol USP).
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