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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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 Pharma - 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 
NDC
ASMF
Venkar Chemicals – WHO-GMP & ISO Certified API Experts Delivering Global Standards.
Together we can improve the quality of life
Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17150
Submission : 2004-02-10
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38843
Submission : 2024-03-07
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36125
Submission : 2021-08-29
Status :
Type : II
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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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Controlled & Modified Release
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Granulation
Co-Processed Excipients
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Taste Masking
Solubilizers
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Digital Content
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Global Sales Information
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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 Rifaximinum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifaximinum, including repackagers and relabelers. The FDA regulates Rifaximinum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifaximinum 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 Rifaximinum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifaximinum supplier is an individual or a company that provides Rifaximinum active pharmaceutical ingredient (API) or Rifaximinum finished formulations upon request. The Rifaximinum suppliers may include Rifaximinum API manufacturers, exporters, distributors and traders.
click here to find a list of Rifaximinum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifaximinum DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifaximinum active pharmaceutical ingredient (API) in detail. Different forms of Rifaximinum DMFs exist exist since differing nations have different regulations, such as Rifaximinum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifaximinum DMF submitted to regulatory agencies in the US is known as a USDMF. Rifaximinum USDMF includes data on Rifaximinum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifaximinum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifaximinum 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 Rifaximinum Drug Master File in Japan (Rifaximinum JDMF) empowers Rifaximinum 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 Rifaximinum JDMF during the approval evaluation for pharmaceutical products. At the time of Rifaximinum 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 Rifaximinum 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 Rifaximinum Drug Master File in Korea (Rifaximinum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rifaximinum. The MFDS reviews the Rifaximinum KDMF as part of the drug registration process and uses the information provided in the Rifaximinum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rifaximinum 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 Rifaximinum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rifaximinum suppliers with KDMF on PharmaCompass.
A Rifaximinum CEP of the European Pharmacopoeia monograph is often referred to as a Rifaximinum Certificate of Suitability (COS). The purpose of a Rifaximinum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifaximinum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifaximinum to their clients by showing that a Rifaximinum CEP has been issued for it. The manufacturer submits a Rifaximinum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifaximinum CEP holder for the record. Additionally, the data presented in the Rifaximinum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifaximinum DMF.
A Rifaximinum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifaximinum 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 Rifaximinum suppliers with CEP (COS) on PharmaCompass.
A Rifaximinum written confirmation (Rifaximinum WC) is an official document issued by a regulatory agency to a Rifaximinum manufacturer, verifying that the manufacturing facility of a Rifaximinum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifaximinum APIs or Rifaximinum finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifaximinum WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifaximinum 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 Rifaximinum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifaximinum 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 Rifaximinum 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 Rifaximinum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifaximinum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifaximinum suppliers with NDC on PharmaCompass.
Rifaximinum 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 Rifaximinum 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 Rifaximinum GMP manufacturer or Rifaximinum GMP API supplier for your needs.
A Rifaximinum CoA (Certificate of Analysis) is a formal document that attests to Rifaximinum's compliance with Rifaximinum specifications and serves as a tool for batch-level quality control.
Rifaximinum CoA mostly includes findings from lab analyses of a specific batch. For each Rifaximinum 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.
Rifaximinum may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifaximinum EP), Rifaximinum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifaximinum USP).
