Synopsis
0
CEP/COS
0
KDMF
0
VMF
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
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]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Empty Capsules
Film Formers & Plasticizers
Thickeners and Stabilizers
Fillers, Diluents & Binders
Topical
Coloring Agents
Lubricants & Glidants
Solubilizers
Direct Compression
Emulsifying Agents
Parenteral
Granulation
Taste Masking
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Trientine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trientine, including repackagers and relabelers. The FDA regulates Trientine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trientine 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 Trientine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trientine supplier is an individual or a company that provides Trientine active pharmaceutical ingredient (API) or Trientine finished formulations upon request. The Trientine suppliers may include Trientine API manufacturers, exporters, distributors and traders.
click here to find a list of Trientine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trientine DMF (Drug Master File) is a document detailing the whole manufacturing process of Trientine active pharmaceutical ingredient (API) in detail. Different forms of Trientine DMFs exist exist since differing nations have different regulations, such as Trientine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trientine DMF submitted to regulatory agencies in the US is known as a USDMF. Trientine USDMF includes data on Trientine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trientine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trientine suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Trientine Drug Master File in Japan (Trientine JDMF) empowers Trientine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Trientine JDMF during the approval evaluation for pharmaceutical products. At the time of Trientine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Trientine suppliers with JDMF on PharmaCompass.
A Trientine written confirmation (Trientine WC) is an official document issued by a regulatory agency to a Trientine manufacturer, verifying that the manufacturing facility of a Trientine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trientine APIs or Trientine finished pharmaceutical products to another nation, regulatory agencies frequently require a Trientine WC (written confirmation) as part of the regulatory process.
click here to find a list of Trientine 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 Trientine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trientine 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 Trientine 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 Trientine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trientine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trientine suppliers with NDC on PharmaCompass.
Trientine 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 Trientine 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 Trientine GMP manufacturer or Trientine GMP API supplier for your needs.
A Trientine CoA (Certificate of Analysis) is a formal document that attests to Trientine's compliance with Trientine specifications and serves as a tool for batch-level quality control.
Trientine CoA mostly includes findings from lab analyses of a specific batch. For each Trientine 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.
Trientine may be tested according to a variety of international standards, such as European Pharmacopoeia (Trientine EP), Trientine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trientine USP).
LOOKING FOR A SUPPLIER?
