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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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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
Lead Product(s) : Rifapentine,Efavirenz,Emtricitabine,Tenofovir Disoproxil Fumarate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Rifapentine is a Antibiotic drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Tuberculosis.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 21, 2012
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SPI Pharma
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Rifapentine 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 Rifapentine manufacturer or Rifapentine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rifapentine manufacturer or Rifapentine supplier.
PharmaCompass also assists you with knowing the Rifapentine API Price utilized in the formulation of products. Rifapentine API Price is not always fixed or binding as the Rifapentine Price is obtained through a variety of data sources. The Rifapentine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A RPT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of RPT, including repackagers and relabelers. The FDA regulates RPT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. RPT 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 RPT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A RPT supplier is an individual or a company that provides RPT active pharmaceutical ingredient (API) or RPT finished formulations upon request. The RPT suppliers may include RPT API manufacturers, exporters, distributors and traders.
click here to find a list of RPT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A RPT DMF (Drug Master File) is a document detailing the whole manufacturing process of RPT active pharmaceutical ingredient (API) in detail. Different forms of RPT DMFs exist exist since differing nations have different regulations, such as RPT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A RPT DMF submitted to regulatory agencies in the US is known as a USDMF. RPT USDMF includes data on RPT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The RPT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of RPT suppliers with USDMF on PharmaCompass.
A RPT written confirmation (RPT WC) is an official document issued by a regulatory agency to a RPT manufacturer, verifying that the manufacturing facility of a RPT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting RPT APIs or RPT finished pharmaceutical products to another nation, regulatory agencies frequently require a RPT WC (written confirmation) as part of the regulatory process.
click here to find a list of RPT 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 RPT as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for RPT 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 RPT 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 RPT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a RPT NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of RPT suppliers with NDC on PharmaCompass.
RPT 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 RPT 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 RPT GMP manufacturer or RPT GMP API supplier for your needs.
A RPT CoA (Certificate of Analysis) is a formal document that attests to RPT's compliance with RPT specifications and serves as a tool for batch-level quality control.
RPT CoA mostly includes findings from lab analyses of a specific batch. For each RPT 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.
RPT may be tested according to a variety of international standards, such as European Pharmacopoeia (RPT EP), RPT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (RPT USP).
