Synopsis
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
US Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
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FDF
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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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API Imports and Exports
Drugs in Development
Lead Product(s) : Sodium Deoxycholate,Moxifloxacin
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluation of the Effect of ATX-101 on QT/QTc Intervals
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 15, 2012
Lead Product(s) : Deoxycholic Acid,Sodium Deoxycholate
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Open-Label Pharmacokinetic Study of Final Formulations of ATX-101
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 03, 2012
Lead Product(s) : Sodium Deoxycholate,ATX-101-BA
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study to Assess Injection Comfort of Two Formulations of ATX-101
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 22, 2011
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sodium Deoxycholate 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 Sodium Deoxycholate manufacturer or Sodium Deoxycholate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Deoxycholate manufacturer or Sodium Deoxycholate supplier.
PharmaCompass also assists you with knowing the Sodium Deoxycholate API Price utilized in the formulation of products. Sodium Deoxycholate API Price is not always fixed or binding as the Sodium Deoxycholate Price is obtained through a variety of data sources. The Sodium Deoxycholate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ATX 101 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ATX 101, including repackagers and relabelers. The FDA regulates ATX 101 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ATX 101 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 ATX 101 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ATX 101 supplier is an individual or a company that provides ATX 101 active pharmaceutical ingredient (API) or ATX 101 finished formulations upon request. The ATX 101 suppliers may include ATX 101 API manufacturers, exporters, distributors and traders.
click here to find a list of ATX 101 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ATX 101 DMF (Drug Master File) is a document detailing the whole manufacturing process of ATX 101 active pharmaceutical ingredient (API) in detail. Different forms of ATX 101 DMFs exist exist since differing nations have different regulations, such as ATX 101 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ATX 101 DMF submitted to regulatory agencies in the US is known as a USDMF. ATX 101 USDMF includes data on ATX 101's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ATX 101 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ATX 101 suppliers with USDMF on PharmaCompass.
A ATX 101 CEP of the European Pharmacopoeia monograph is often referred to as a ATX 101 Certificate of Suitability (COS). The purpose of a ATX 101 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ATX 101 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ATX 101 to their clients by showing that a ATX 101 CEP has been issued for it. The manufacturer submits a ATX 101 CEP (COS) as part of the market authorization procedure, and it takes on the role of a ATX 101 CEP holder for the record. Additionally, the data presented in the ATX 101 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ATX 101 DMF.
A ATX 101 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ATX 101 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of ATX 101 suppliers with CEP (COS) on PharmaCompass.
ATX 101 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 ATX 101 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 ATX 101 GMP manufacturer or ATX 101 GMP API supplier for your needs.
A ATX 101 CoA (Certificate of Analysis) is a formal document that attests to ATX 101's compliance with ATX 101 specifications and serves as a tool for batch-level quality control.
ATX 101 CoA mostly includes findings from lab analyses of a specific batch. For each ATX 101 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.
ATX 101 may be tested according to a variety of international standards, such as European Pharmacopoeia (ATX 101 EP), ATX 101 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ATX 101 USP).
Comment (3)
