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