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API SUPPLIERS
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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
Related Excipient Companies
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 Antepsin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Antepsin, including repackagers and relabelers. The FDA regulates Antepsin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Antepsin 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 Antepsin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Antepsin supplier is an individual or a company that provides Antepsin active pharmaceutical ingredient (API) or Antepsin finished formulations upon request. The Antepsin suppliers may include Antepsin API manufacturers, exporters, distributors and traders.
click here to find a list of Antepsin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Antepsin DMF (Drug Master File) is a document detailing the whole manufacturing process of Antepsin active pharmaceutical ingredient (API) in detail. Different forms of Antepsin DMFs exist exist since differing nations have different regulations, such as Antepsin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Antepsin DMF submitted to regulatory agencies in the US is known as a USDMF. Antepsin USDMF includes data on Antepsin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Antepsin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Antepsin 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 Antepsin Drug Master File in Japan (Antepsin JDMF) empowers Antepsin 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 Antepsin JDMF during the approval evaluation for pharmaceutical products. At the time of Antepsin 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 Antepsin 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 Antepsin Drug Master File in Korea (Antepsin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Antepsin. The MFDS reviews the Antepsin KDMF as part of the drug registration process and uses the information provided in the Antepsin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Antepsin 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 Antepsin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Antepsin suppliers with KDMF on PharmaCompass.
A Antepsin CEP of the European Pharmacopoeia monograph is often referred to as a Antepsin Certificate of Suitability (COS). The purpose of a Antepsin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Antepsin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Antepsin to their clients by showing that a Antepsin CEP has been issued for it. The manufacturer submits a Antepsin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Antepsin CEP holder for the record. Additionally, the data presented in the Antepsin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Antepsin DMF.
A Antepsin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Antepsin 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 Antepsin suppliers with CEP (COS) on PharmaCompass.
A Antepsin written confirmation (Antepsin WC) is an official document issued by a regulatory agency to a Antepsin manufacturer, verifying that the manufacturing facility of a Antepsin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Antepsin APIs or Antepsin finished pharmaceutical products to another nation, regulatory agencies frequently require a Antepsin WC (written confirmation) as part of the regulatory process.
click here to find a list of Antepsin 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 Antepsin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Antepsin 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 Antepsin 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 Antepsin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Antepsin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Antepsin suppliers with NDC on PharmaCompass.
Antepsin 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 Antepsin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Antepsin GMP manufacturer or Antepsin GMP API supplier for your needs.
A Antepsin CoA (Certificate of Analysis) is a formal document that attests to Antepsin's compliance with Antepsin specifications and serves as a tool for batch-level quality control.
Antepsin CoA mostly includes findings from lab analyses of a specific batch. For each Antepsin 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.
Antepsin may be tested according to a variety of international standards, such as European Pharmacopoeia (Antepsin EP), Antepsin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Antepsin USP).
