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USDMF
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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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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Sorbitol’s bulk sweetness and compatibility with active ingredients makes it an ideal taste masking agent in pharmaceutical formulations.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking
Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
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ABOUT THIS PAGE
53
PharmaCompass offers a list of Sucralfate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Sucralfat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucralfat, including repackagers and relabelers. The FDA regulates Sucralfat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucralfat 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 Sucralfat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sucralfat supplier is an individual or a company that provides Sucralfat active pharmaceutical ingredient (API) or Sucralfat finished formulations upon request. The Sucralfat suppliers may include Sucralfat API manufacturers, exporters, distributors and traders.
click here to find a list of Sucralfat suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sucralfat DMF (Drug Master File) is a document detailing the whole manufacturing process of Sucralfat active pharmaceutical ingredient (API) in detail. Different forms of Sucralfat DMFs exist exist since differing nations have different regulations, such as Sucralfat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sucralfat DMF submitted to regulatory agencies in the US is known as a USDMF. Sucralfat USDMF includes data on Sucralfat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sucralfat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sucralfat 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 Sucralfat Drug Master File in Japan (Sucralfat JDMF) empowers Sucralfat 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 Sucralfat JDMF during the approval evaluation for pharmaceutical products. At the time of Sucralfat 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 Sucralfat 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 Sucralfat Drug Master File in Korea (Sucralfat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sucralfat. The MFDS reviews the Sucralfat KDMF as part of the drug registration process and uses the information provided in the Sucralfat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sucralfat 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 Sucralfat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sucralfat suppliers with KDMF on PharmaCompass.
A Sucralfat CEP of the European Pharmacopoeia monograph is often referred to as a Sucralfat Certificate of Suitability (COS). The purpose of a Sucralfat CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sucralfat EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sucralfat to their clients by showing that a Sucralfat CEP has been issued for it. The manufacturer submits a Sucralfat CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sucralfat CEP holder for the record. Additionally, the data presented in the Sucralfat CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sucralfat DMF.
A Sucralfat CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sucralfat 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 Sucralfat suppliers with CEP (COS) on PharmaCompass.
A Sucralfat written confirmation (Sucralfat WC) is an official document issued by a regulatory agency to a Sucralfat manufacturer, verifying that the manufacturing facility of a Sucralfat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sucralfat APIs or Sucralfat finished pharmaceutical products to another nation, regulatory agencies frequently require a Sucralfat WC (written confirmation) as part of the regulatory process.
click here to find a list of Sucralfat 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 Sucralfat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sucralfat 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 Sucralfat 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 Sucralfat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sucralfat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sucralfat suppliers with NDC on PharmaCompass.
Sucralfat 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 Sucralfat GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sucralfat GMP manufacturer or Sucralfat GMP API supplier for your needs.
A Sucralfat CoA (Certificate of Analysis) is a formal document that attests to Sucralfat's compliance with Sucralfat specifications and serves as a tool for batch-level quality control.
Sucralfat CoA mostly includes findings from lab analyses of a specific batch. For each Sucralfat 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.
Sucralfat may be tested according to a variety of international standards, such as European Pharmacopoeia (Sucralfat EP), Sucralfat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sucralfat USP).
