Synopsis
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CEP/COS
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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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FDA Orange Book
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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US Patents
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
Axplora is your partner of choice for complex APIs.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31049
Submission : 2016-09-30
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
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...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
About the Company : ICE Pharma's core business includes the manufacture of active pharmaceutical ingredients, the most important of which is Ursodeoxycholic Acid (UDCA), used to treat liver diseases a...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Tauroursodeoxycholic Acid 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 Tauroursodeoxycholic Acid manufacturer or Tauroursodeoxycholic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tauroursodeoxycholic Acid manufacturer or Tauroursodeoxycholic Acid supplier.
PharmaCompass also assists you with knowing the Tauroursodeoxycholic Acid API Price utilized in the formulation of products. Tauroursodeoxycholic Acid API Price is not always fixed or binding as the Tauroursodeoxycholic Acid Price is obtained through a variety of data sources. The Tauroursodeoxycholic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Taurursodiol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Taurursodiol, including repackagers and relabelers. The FDA regulates Taurursodiol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Taurursodiol 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 Taurursodiol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Taurursodiol supplier is an individual or a company that provides Taurursodiol active pharmaceutical ingredient (API) or Taurursodiol finished formulations upon request. The Taurursodiol suppliers may include Taurursodiol API manufacturers, exporters, distributors and traders.
click here to find a list of Taurursodiol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Taurursodiol DMF (Drug Master File) is a document detailing the whole manufacturing process of Taurursodiol active pharmaceutical ingredient (API) in detail. Different forms of Taurursodiol DMFs exist exist since differing nations have different regulations, such as Taurursodiol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Taurursodiol DMF submitted to regulatory agencies in the US is known as a USDMF. Taurursodiol USDMF includes data on Taurursodiol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Taurursodiol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Taurursodiol 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 Taurursodiol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Taurursodiol 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 Taurursodiol 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 Taurursodiol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Taurursodiol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Taurursodiol suppliers with NDC on PharmaCompass.
Taurursodiol 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 Taurursodiol 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 Taurursodiol GMP manufacturer or Taurursodiol GMP API supplier for your needs.
A Taurursodiol CoA (Certificate of Analysis) is a formal document that attests to Taurursodiol's compliance with Taurursodiol specifications and serves as a tool for batch-level quality control.
Taurursodiol CoA mostly includes findings from lab analyses of a specific batch. For each Taurursodiol 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.
Taurursodiol may be tested according to a variety of international standards, such as European Pharmacopoeia (Taurursodiol EP), Taurursodiol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Taurursodiol USP).
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