Synopsis
0
EU WC
0
VMF
0
FDA Orange Book
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
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]CEP/COS
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/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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]Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
100
PharmaCompass offers a list of Trimebutine Maleate 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 Trimebutine Maleate manufacturer or Trimebutine Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trimebutine Maleate manufacturer or Trimebutine Maleate supplier.
PharmaCompass also assists you with knowing the Trimebutine Maleate API Price utilized in the formulation of products. Trimebutine Maleate API Price is not always fixed or binding as the Trimebutine Maleate Price is obtained through a variety of data sources. The Trimebutine Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Trimebutine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trimebutine, including repackagers and relabelers. The FDA regulates Trimebutine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trimebutine 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 Trimebutine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trimebutine supplier is an individual or a company that provides Trimebutine active pharmaceutical ingredient (API) or Trimebutine finished formulations upon request. The Trimebutine suppliers may include Trimebutine API manufacturers, exporters, distributors and traders.
click here to find a list of Trimebutine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trimebutine DMF (Drug Master File) is a document detailing the whole manufacturing process of Trimebutine active pharmaceutical ingredient (API) in detail. Different forms of Trimebutine DMFs exist exist since differing nations have different regulations, such as Trimebutine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trimebutine DMF submitted to regulatory agencies in the US is known as a USDMF. Trimebutine USDMF includes data on Trimebutine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trimebutine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trimebutine 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 Trimebutine Drug Master File in Japan (Trimebutine JDMF) empowers Trimebutine 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 Trimebutine JDMF during the approval evaluation for pharmaceutical products. At the time of Trimebutine 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 Trimebutine suppliers with JDMF 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 Trimebutine Drug Master File in Korea (Trimebutine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trimebutine. The MFDS reviews the Trimebutine KDMF as part of the drug registration process and uses the information provided in the Trimebutine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trimebutine 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 Trimebutine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trimebutine suppliers with KDMF on PharmaCompass.
A Trimebutine CEP of the European Pharmacopoeia monograph is often referred to as a Trimebutine Certificate of Suitability (COS). The purpose of a Trimebutine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trimebutine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trimebutine to their clients by showing that a Trimebutine CEP has been issued for it. The manufacturer submits a Trimebutine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trimebutine CEP holder for the record. Additionally, the data presented in the Trimebutine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trimebutine DMF.
A Trimebutine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trimebutine 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 Trimebutine suppliers with CEP (COS) 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 Trimebutine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trimebutine 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 Trimebutine 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 Trimebutine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trimebutine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trimebutine suppliers with NDC on PharmaCompass.
Trimebutine 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 Trimebutine 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 Trimebutine GMP manufacturer or Trimebutine GMP API supplier for your needs.
A Trimebutine CoA (Certificate of Analysis) is a formal document that attests to Trimebutine's compliance with Trimebutine specifications and serves as a tool for batch-level quality control.
Trimebutine CoA mostly includes findings from lab analyses of a specific batch. For each Trimebutine 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.
Trimebutine may be tested according to a variety of international standards, such as European Pharmacopoeia (Trimebutine EP), Trimebutine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trimebutine USP).
