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ABOUT THIS PAGE
A Trimebutine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trimebutine Maleate, including repackagers and relabelers. The FDA regulates Trimebutine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trimebutine Maleate 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 Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trimebutine Maleate supplier is an individual or a company that provides Trimebutine Maleate active pharmaceutical ingredient (API) or Trimebutine Maleate finished formulations upon request. The Trimebutine Maleate suppliers may include Trimebutine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Trimebutine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trimebutine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Trimebutine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Trimebutine Maleate DMFs exist exist since differing nations have different regulations, such as Trimebutine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trimebutine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Trimebutine Maleate USDMF includes data on Trimebutine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trimebutine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trimebutine Maleate 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 Maleate Drug Master File in Japan (Trimebutine Maleate JDMF) empowers Trimebutine Maleate 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 Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Trimebutine Maleate 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 Maleate 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 Maleate Drug Master File in Korea (Trimebutine Maleate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trimebutine Maleate. The MFDS reviews the Trimebutine Maleate KDMF as part of the drug registration process and uses the information provided in the Trimebutine Maleate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trimebutine Maleate 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 Maleate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trimebutine Maleate suppliers with KDMF on PharmaCompass.
A Trimebutine Maleate CEP of the European Pharmacopoeia monograph is often referred to as a Trimebutine Maleate Certificate of Suitability (COS). The purpose of a Trimebutine Maleate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trimebutine Maleate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trimebutine Maleate to their clients by showing that a Trimebutine Maleate CEP has been issued for it. The manufacturer submits a Trimebutine Maleate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trimebutine Maleate CEP holder for the record. Additionally, the data presented in the Trimebutine Maleate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trimebutine Maleate DMF.
A Trimebutine Maleate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trimebutine Maleate 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 Maleate 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 Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trimebutine Maleate 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 Maleate 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 Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trimebutine Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trimebutine Maleate suppliers with NDC on PharmaCompass.
Trimebutine Maleate 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 Maleate 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 Maleate GMP manufacturer or Trimebutine Maleate GMP API supplier for your needs.
A Trimebutine Maleate CoA (Certificate of Analysis) is a formal document that attests to Trimebutine Maleate's compliance with Trimebutine Maleate specifications and serves as a tool for batch-level quality control.
Trimebutine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Trimebutine Maleate 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 Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Trimebutine Maleate EP), Trimebutine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trimebutine Maleate USP).
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