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DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Certificate Number : CEP 2012-146 - Rev 02
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 2362
Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.
Certificate Number : CEP 2022-368 - Rev 00
Status : Valid
Issue Date : 2024-09-02
Type : Chemical
Substance Number : 2362
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registration Number : 226MF10147
Registrant's Address : Via Angelo Titi, 22/26, Zona ex punto franco, 72100 Brindisi, Italy
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2014-09-01
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-05-04
Registration Number : 20220504-209-J-1285
Manufacturer Name : EUROAPI ITALY SRL
Manufacturer Address : Via Angelo TiTi, 22/26 - 72100 Brindisi (BR)
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
CAS Number : 14487-05-9
End Use API : Rifaximin
About The Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs...
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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 550MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 550MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Tablet
Dosage Strength : 550MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
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DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 21361
DOSAGE - TABLET;ORAL - 550MG
USFDA APPLICATION NUMBER - 21361
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Rifaximin 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 Rifaximin manufacturer or Rifaximin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rifaximin manufacturer or Rifaximin supplier.
PharmaCompass also assists you with knowing the Rifaximin API Price utilized in the formulation of products. Rifaximin API Price is not always fixed or binding as the Rifaximin Price is obtained through a variety of data sources. The Rifaximin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rifaximin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifaximin, including repackagers and relabelers. The FDA regulates Rifaximin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifaximin 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 Rifaximin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifaximin supplier is an individual or a company that provides Rifaximin active pharmaceutical ingredient (API) or Rifaximin finished formulations upon request. The Rifaximin suppliers may include Rifaximin API manufacturers, exporters, distributors and traders.
click here to find a list of Rifaximin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifaximin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifaximin active pharmaceutical ingredient (API) in detail. Different forms of Rifaximin DMFs exist exist since differing nations have different regulations, such as Rifaximin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifaximin DMF submitted to regulatory agencies in the US is known as a USDMF. Rifaximin USDMF includes data on Rifaximin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifaximin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifaximin 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 Rifaximin Drug Master File in Japan (Rifaximin JDMF) empowers Rifaximin 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 Rifaximin JDMF during the approval evaluation for pharmaceutical products. At the time of Rifaximin 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 Rifaximin 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 Rifaximin Drug Master File in Korea (Rifaximin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rifaximin. The MFDS reviews the Rifaximin KDMF as part of the drug registration process and uses the information provided in the Rifaximin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rifaximin 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 Rifaximin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rifaximin suppliers with KDMF on PharmaCompass.
A Rifaximin CEP of the European Pharmacopoeia monograph is often referred to as a Rifaximin Certificate of Suitability (COS). The purpose of a Rifaximin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifaximin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifaximin to their clients by showing that a Rifaximin CEP has been issued for it. The manufacturer submits a Rifaximin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifaximin CEP holder for the record. Additionally, the data presented in the Rifaximin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifaximin DMF.
A Rifaximin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifaximin 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 Rifaximin suppliers with CEP (COS) on PharmaCompass.
A Rifaximin written confirmation (Rifaximin WC) is an official document issued by a regulatory agency to a Rifaximin manufacturer, verifying that the manufacturing facility of a Rifaximin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifaximin APIs or Rifaximin finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifaximin WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifaximin 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 Rifaximin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifaximin 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 Rifaximin 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 Rifaximin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifaximin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifaximin suppliers with NDC on PharmaCompass.
Rifaximin 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 Rifaximin 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 Rifaximin GMP manufacturer or Rifaximin GMP API supplier for your needs.
A Rifaximin CoA (Certificate of Analysis) is a formal document that attests to Rifaximin's compliance with Rifaximin specifications and serves as a tool for batch-level quality control.
Rifaximin CoA mostly includes findings from lab analyses of a specific batch. For each Rifaximin 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.
Rifaximin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifaximin EP), Rifaximin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifaximin USP).
