Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
EDQM
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USP
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JP
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Others
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - EQ 150MG BASE
USFDA APPLICATION NUMBER - 21985
DOSAGE - TABLET;ORAL - EQ 300MG BASE
USFDA APPLICATION NUMBER - 21985
DOSAGE - TABLET;ORAL - EQ 150MG BASE;12.5MG *...DOSAGE - TABLET;ORAL - EQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22107
DOSAGE - TABLET;ORAL - EQ 150MG BASE;25MG **F...DOSAGE - TABLET;ORAL - EQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22107
DOSAGE - TABLET;ORAL - EQ 300MG BASE;12.5MG *...DOSAGE - TABLET;ORAL - EQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22107
DOSAGE - TABLET;ORAL - EQ 300MG BASE;25MG **F...DOSAGE - TABLET;ORAL - EQ 300MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22107
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ABOUT THIS PAGE
A Aliskiren manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aliskiren, including repackagers and relabelers. The FDA regulates Aliskiren manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aliskiren 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 Aliskiren manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aliskiren supplier is an individual or a company that provides Aliskiren active pharmaceutical ingredient (API) or Aliskiren finished formulations upon request. The Aliskiren suppliers may include Aliskiren API manufacturers, exporters, distributors and traders.
click here to find a list of Aliskiren suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aliskiren DMF (Drug Master File) is a document detailing the whole manufacturing process of Aliskiren active pharmaceutical ingredient (API) in detail. Different forms of Aliskiren DMFs exist exist since differing nations have different regulations, such as Aliskiren USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aliskiren DMF submitted to regulatory agencies in the US is known as a USDMF. Aliskiren USDMF includes data on Aliskiren's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aliskiren USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aliskiren suppliers with USDMF on PharmaCompass.
A Aliskiren written confirmation (Aliskiren WC) is an official document issued by a regulatory agency to a Aliskiren manufacturer, verifying that the manufacturing facility of a Aliskiren active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aliskiren APIs or Aliskiren finished pharmaceutical products to another nation, regulatory agencies frequently require a Aliskiren WC (written confirmation) as part of the regulatory process.
click here to find a list of Aliskiren 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 Aliskiren as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aliskiren 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 Aliskiren 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 Aliskiren and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aliskiren NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aliskiren suppliers with NDC on PharmaCompass.
Aliskiren 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 Aliskiren 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 Aliskiren GMP manufacturer or Aliskiren GMP API supplier for your needs.
A Aliskiren CoA (Certificate of Analysis) is a formal document that attests to Aliskiren's compliance with Aliskiren specifications and serves as a tool for batch-level quality control.
Aliskiren CoA mostly includes findings from lab analyses of a specific batch. For each Aliskiren 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.
Aliskiren may be tested according to a variety of international standards, such as European Pharmacopoeia (Aliskiren EP), Aliskiren JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aliskiren USP).
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