Synopsis
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JDMF
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EU WC
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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FDF Dossiers
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FDA Orange Book
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Europe
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Listed Dossiers
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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
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37340
Submission : 2022-10-19
Status :
Type : II
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ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
About the Company : Founded in 2006, ChemExpress provides CRO and CDMO services to pharmaceutical and biotech companies. The company supports small molecules, biologics, and new modalities such as ADC...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Elobixibat 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 Elobixibat manufacturer or Elobixibat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Elobixibat manufacturer or Elobixibat supplier.
PharmaCompass also assists you with knowing the Elobixibat API Price utilized in the formulation of products. Elobixibat API Price is not always fixed or binding as the Elobixibat Price is obtained through a variety of data sources. The Elobixibat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Elobixibat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elobixibat, including repackagers and relabelers. The FDA regulates Elobixibat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elobixibat 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 Elobixibat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elobixibat supplier is an individual or a company that provides Elobixibat active pharmaceutical ingredient (API) or Elobixibat finished formulations upon request. The Elobixibat suppliers may include Elobixibat API manufacturers, exporters, distributors and traders.
click here to find a list of Elobixibat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Elobixibat DMF (Drug Master File) is a document detailing the whole manufacturing process of Elobixibat active pharmaceutical ingredient (API) in detail. Different forms of Elobixibat DMFs exist exist since differing nations have different regulations, such as Elobixibat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elobixibat DMF submitted to regulatory agencies in the US is known as a USDMF. Elobixibat USDMF includes data on Elobixibat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elobixibat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elobixibat suppliers with USDMF 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 Elobixibat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elobixibat 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 Elobixibat 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 Elobixibat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elobixibat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elobixibat suppliers with NDC on PharmaCompass.
Elobixibat 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 Elobixibat 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 Elobixibat GMP manufacturer or Elobixibat GMP API supplier for your needs.
A Elobixibat CoA (Certificate of Analysis) is a formal document that attests to Elobixibat's compliance with Elobixibat specifications and serves as a tool for batch-level quality control.
Elobixibat CoA mostly includes findings from lab analyses of a specific batch. For each Elobixibat 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.
Elobixibat may be tested according to a variety of international standards, such as European Pharmacopoeia (Elobixibat EP), Elobixibat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elobixibat USP).
Comment (11)
