Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
US Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
0
FDF
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Market Place
ABOUT THIS PAGE
16
PharmaCompass offers a list of Taurolidine 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 Taurolidine manufacturer or Taurolidine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Taurolidine manufacturer or Taurolidine supplier.
PharmaCompass also assists you with knowing the Taurolidine API Price utilized in the formulation of products. Taurolidine API Price is not always fixed or binding as the Taurolidine Price is obtained through a variety of data sources. The Taurolidine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tauroline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tauroline, including repackagers and relabelers. The FDA regulates Tauroline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tauroline 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 Tauroline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tauroline supplier is an individual or a company that provides Tauroline active pharmaceutical ingredient (API) or Tauroline finished formulations upon request. The Tauroline suppliers may include Tauroline API manufacturers, exporters, distributors and traders.
click here to find a list of Tauroline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tauroline DMF (Drug Master File) is a document detailing the whole manufacturing process of Tauroline active pharmaceutical ingredient (API) in detail. Different forms of Tauroline DMFs exist exist since differing nations have different regulations, such as Tauroline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tauroline DMF submitted to regulatory agencies in the US is known as a USDMF. Tauroline USDMF includes data on Tauroline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tauroline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tauroline suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Tauroline Drug Master File in Korea (Tauroline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tauroline. The MFDS reviews the Tauroline KDMF as part of the drug registration process and uses the information provided in the Tauroline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tauroline KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tauroline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tauroline suppliers with KDMF on PharmaCompass.
A Tauroline written confirmation (Tauroline WC) is an official document issued by a regulatory agency to a Tauroline manufacturer, verifying that the manufacturing facility of a Tauroline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tauroline APIs or Tauroline finished pharmaceutical products to another nation, regulatory agencies frequently require a Tauroline WC (written confirmation) as part of the regulatory process.
click here to find a list of Tauroline 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 Tauroline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tauroline 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 Tauroline 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 Tauroline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tauroline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tauroline suppliers with NDC on PharmaCompass.
Tauroline 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 Tauroline 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 Tauroline GMP manufacturer or Tauroline GMP API supplier for your needs.
A Tauroline CoA (Certificate of Analysis) is a formal document that attests to Tauroline's compliance with Tauroline specifications and serves as a tool for batch-level quality control.
Tauroline CoA mostly includes findings from lab analyses of a specific batch. For each Tauroline 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.
Tauroline may be tested according to a variety of international standards, such as European Pharmacopoeia (Tauroline EP), Tauroline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tauroline USP).
