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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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KDMF
ASMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
CEP/COS
EU-WC
NDC
ASMF
Venkar Chemicals – WHO-GMP & ISO Certified API Experts Delivering Global Standards.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
CEP/COS
NDC
ASMF
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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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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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 Rifamixin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifamixin, including repackagers and relabelers. The FDA regulates Rifamixin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifamixin 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 Rifamixin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifamixin supplier is an individual or a company that provides Rifamixin active pharmaceutical ingredient (API) or Rifamixin finished formulations upon request. The Rifamixin suppliers may include Rifamixin API manufacturers, exporters, distributors and traders.
click here to find a list of Rifamixin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifamixin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifamixin active pharmaceutical ingredient (API) in detail. Different forms of Rifamixin DMFs exist exist since differing nations have different regulations, such as Rifamixin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifamixin DMF submitted to regulatory agencies in the US is known as a USDMF. Rifamixin USDMF includes data on Rifamixin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifamixin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifamixin 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 Rifamixin Drug Master File in Japan (Rifamixin JDMF) empowers Rifamixin 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 Rifamixin JDMF during the approval evaluation for pharmaceutical products. At the time of Rifamixin 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 Rifamixin 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 Rifamixin Drug Master File in Korea (Rifamixin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rifamixin. The MFDS reviews the Rifamixin KDMF as part of the drug registration process and uses the information provided in the Rifamixin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rifamixin 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 Rifamixin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rifamixin suppliers with KDMF on PharmaCompass.
A Rifamixin CEP of the European Pharmacopoeia monograph is often referred to as a Rifamixin Certificate of Suitability (COS). The purpose of a Rifamixin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifamixin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifamixin to their clients by showing that a Rifamixin CEP has been issued for it. The manufacturer submits a Rifamixin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifamixin CEP holder for the record. Additionally, the data presented in the Rifamixin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifamixin DMF.
A Rifamixin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifamixin 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 Rifamixin suppliers with CEP (COS) on PharmaCompass.
A Rifamixin written confirmation (Rifamixin WC) is an official document issued by a regulatory agency to a Rifamixin manufacturer, verifying that the manufacturing facility of a Rifamixin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifamixin APIs or Rifamixin finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifamixin WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifamixin 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 Rifamixin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifamixin 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 Rifamixin 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 Rifamixin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifamixin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifamixin suppliers with NDC on PharmaCompass.
Rifamixin 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 Rifamixin 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 Rifamixin GMP manufacturer or Rifamixin GMP API supplier for your needs.
A Rifamixin CoA (Certificate of Analysis) is a formal document that attests to Rifamixin's compliance with Rifamixin specifications and serves as a tool for batch-level quality control.
Rifamixin CoA mostly includes findings from lab analyses of a specific batch. For each Rifamixin 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.
Rifamixin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifamixin EP), Rifamixin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifamixin USP).
