Synopsis
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JDMF
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VMF
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Europe
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DRUG PRODUCT COMPOSITIONS
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Molecular Weight | 877.0 g/mol |
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Molecular Formula | C47H64N4O12 |
XLogP3 | 5.8 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 15 |
Rotatable Bond Count | 6 |
Exact Mass | 876.45207349 g/mol |
Monoisotopic Mass | 876.45207349 g/mol |
Topological Polar Surface Area | 217 A^2 |
Heavy Atom Count | 63 |
Formal Charge | 0 |
Complexity | 1870 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 9 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 4 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
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Drug Name | Priftin |
PubMed Health | Rifapentine (By mouth) |
Drug Classes | Antitubercular |
Drug Label | PRIFTIN (rifapentine) for oral administration contains 150 mg of the active ingredient rifapentine per tablet. The 150 mg tablets also contain, as inactive ingredients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum lake, hydroxypropyl cel. |
Active Ingredient | Rifapentine |
Dosage Form | Tablet |
Route | Oral |
Strength | 150mg |
Market Status | Prescription |
Company | Sanofi Aventis Us |
2 of 2 | |
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Drug Name | Priftin |
PubMed Health | Rifapentine (By mouth) |
Drug Classes | Antitubercular |
Drug Label | PRIFTIN (rifapentine) for oral administration contains 150 mg of the active ingredient rifapentine per tablet. The 150 mg tablets also contain, as inactive ingredients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum lake, hydroxypropyl cel. |
Active Ingredient | Rifapentine |
Dosage Form | Tablet |
Route | Oral |
Strength | 150mg |
Market Status | Prescription |
Company | Sanofi Aventis Us |
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Rifapentine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifapentine, including repackagers and relabelers. The FDA regulates Rifapentine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifapentine 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 Rifapentine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifapentine supplier is an individual or a company that provides Rifapentine active pharmaceutical ingredient (API) or Rifapentine finished formulations upon request. The Rifapentine suppliers may include Rifapentine API manufacturers, exporters, distributors and traders.
click here to find a list of Rifapentine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifapentine DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifapentine active pharmaceutical ingredient (API) in detail. Different forms of Rifapentine DMFs exist exist since differing nations have different regulations, such as Rifapentine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifapentine DMF submitted to regulatory agencies in the US is known as a USDMF. Rifapentine USDMF includes data on Rifapentine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifapentine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifapentine suppliers with USDMF on PharmaCompass.
A Rifapentine written confirmation (Rifapentine WC) is an official document issued by a regulatory agency to a Rifapentine manufacturer, verifying that the manufacturing facility of a Rifapentine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifapentine APIs or Rifapentine finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifapentine WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifapentine 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 Rifapentine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifapentine 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 Rifapentine 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 Rifapentine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifapentine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifapentine suppliers with NDC on PharmaCompass.
Rifapentine 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 Rifapentine 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 Rifapentine GMP manufacturer or Rifapentine GMP API supplier for your needs.
A Rifapentine CoA (Certificate of Analysis) is a formal document that attests to Rifapentine's compliance with Rifapentine specifications and serves as a tool for batch-level quality control.
Rifapentine CoA mostly includes findings from lab analyses of a specific batch. For each Rifapentine 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.
Rifapentine may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifapentine EP), Rifapentine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifapentine USP).
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