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DRUG PRODUCT COMPOSITIONS0
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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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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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DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 21361
DOSAGE - TABLET;ORAL - 550MG
USFDA APPLICATION NUMBER - 21361
Related Excipient Companies
SPI Pharma
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DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Application : Emulsifying Agents
Excipient Details : HDK N20 Pharma is used as a pharmaceutical emulsifying agent in tablets, capsules, syrups, and solutions.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Oral, Topical
Application : Rheology Modifiers
Excipient Details : HPMC 60HD4000 is used as thickener and viscosity modifier in oral solid, liquid and topical dosage forms.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Suspension
Grade : Oral
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
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Fillers, Diluents & Binders
Controlled & Modified Release
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Direct Compression
Granulation
Film Formers & Plasticizers
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgels
Grade : Parenteral, Oral, Topical
Application : Film Formers & Plasticizers, Parenteral, Thickeners and Stabilizers, Topical
Excipient Details : Propylene glycol is used as a solvent & stabilizer in injections. It is also used in topical semi-solids & as a plasticizer in soft capsules.
Co-Processed Excipients
Empty Capsules
API Stability Enhancers
Lubricants & Glidants
Vegetarian Capsules
Taste Masking
Coloring Agents
Emulsifying Agents
Topical
Rheology Modifiers
Chewable & Orodispersible Aids
Solubilizers
Parenteral
Digital Content
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Global Sales Information
US Medicaid Prescriptions
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USP
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
CAS Number : 14487-05-9
Quantity Per Vial :
Price ($) : 700
Catalog Number : 1A03810
Current Lot : 25 mg
Previous Lot :
NDC Code :
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 Fatroximin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fatroximin, including repackagers and relabelers. The FDA regulates Fatroximin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fatroximin 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 Fatroximin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fatroximin supplier is an individual or a company that provides Fatroximin active pharmaceutical ingredient (API) or Fatroximin finished formulations upon request. The Fatroximin suppliers may include Fatroximin API manufacturers, exporters, distributors and traders.
click here to find a list of Fatroximin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fatroximin DMF (Drug Master File) is a document detailing the whole manufacturing process of Fatroximin active pharmaceutical ingredient (API) in detail. Different forms of Fatroximin DMFs exist exist since differing nations have different regulations, such as Fatroximin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fatroximin DMF submitted to regulatory agencies in the US is known as a USDMF. Fatroximin USDMF includes data on Fatroximin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fatroximin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fatroximin 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 Fatroximin Drug Master File in Japan (Fatroximin JDMF) empowers Fatroximin 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 Fatroximin JDMF during the approval evaluation for pharmaceutical products. At the time of Fatroximin 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 Fatroximin 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 Fatroximin Drug Master File in Korea (Fatroximin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fatroximin. The MFDS reviews the Fatroximin KDMF as part of the drug registration process and uses the information provided in the Fatroximin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fatroximin 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 Fatroximin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fatroximin suppliers with KDMF on PharmaCompass.
A Fatroximin CEP of the European Pharmacopoeia monograph is often referred to as a Fatroximin Certificate of Suitability (COS). The purpose of a Fatroximin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fatroximin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fatroximin to their clients by showing that a Fatroximin CEP has been issued for it. The manufacturer submits a Fatroximin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fatroximin CEP holder for the record. Additionally, the data presented in the Fatroximin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fatroximin DMF.
A Fatroximin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fatroximin 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 Fatroximin suppliers with CEP (COS) on PharmaCompass.
A Fatroximin written confirmation (Fatroximin WC) is an official document issued by a regulatory agency to a Fatroximin manufacturer, verifying that the manufacturing facility of a Fatroximin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fatroximin APIs or Fatroximin finished pharmaceutical products to another nation, regulatory agencies frequently require a Fatroximin WC (written confirmation) as part of the regulatory process.
click here to find a list of Fatroximin 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 Fatroximin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fatroximin 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 Fatroximin 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 Fatroximin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fatroximin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fatroximin suppliers with NDC on PharmaCompass.
Fatroximin 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 Fatroximin 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 Fatroximin GMP manufacturer or Fatroximin GMP API supplier for your needs.
A Fatroximin CoA (Certificate of Analysis) is a formal document that attests to Fatroximin's compliance with Fatroximin specifications and serves as a tool for batch-level quality control.
Fatroximin CoA mostly includes findings from lab analyses of a specific batch. For each Fatroximin 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.
Fatroximin may be tested according to a variety of international standards, such as European Pharmacopoeia (Fatroximin EP), Fatroximin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fatroximin USP).
