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API SUPPLIERS
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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USDMF
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Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
N-Methyl-4- Hydroxy Piperidine
CAS Number : 106-52-5
End Use API : Domperidone
About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and in...
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
CAS Number : 29976-53-2
End Use API : Domperidone
About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer specializing in anti-asthmatic, anti-migraine, and anti-psychotic APIs for domestic and in...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
1-(3-Chloropropyl)-1,3-dihydro-2H-benzimidazol-2-o...
CAS Number : 62780-89-6
End Use API : Domperidone
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
5-Chloro-1-piperidine-4-yl-1,3-dihydro-2H-benzimid...
CAS Number : 53786-28-0
End Use API : Domperidone
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Ethyl 4-aminopiperidine-1-carboxylate
CAS Number : 58859-46-4
End Use API : Domperidone
About The Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-g...
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REF. STANDARDS & IMPURITIES
ANALYTICAL
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, 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.
A Domperidon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Domperidon, including repackagers and relabelers. The FDA regulates Domperidon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Domperidon 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 Domperidon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Domperidon supplier is an individual or a company that provides Domperidon active pharmaceutical ingredient (API) or Domperidon finished formulations upon request. The Domperidon suppliers may include Domperidon API manufacturers, exporters, distributors and traders.
click here to find a list of Domperidon suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Domperidon DMF (Drug Master File) is a document detailing the whole manufacturing process of Domperidon active pharmaceutical ingredient (API) in detail. Different forms of Domperidon DMFs exist exist since differing nations have different regulations, such as Domperidon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Domperidon DMF submitted to regulatory agencies in the US is known as a USDMF. Domperidon USDMF includes data on Domperidon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Domperidon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Domperidon 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 Domperidon Drug Master File in Japan (Domperidon JDMF) empowers Domperidon 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 Domperidon JDMF during the approval evaluation for pharmaceutical products. At the time of Domperidon 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 Domperidon 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 Domperidon Drug Master File in Korea (Domperidon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Domperidon. The MFDS reviews the Domperidon KDMF as part of the drug registration process and uses the information provided in the Domperidon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Domperidon 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 Domperidon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Domperidon suppliers with KDMF on PharmaCompass.
A Domperidon CEP of the European Pharmacopoeia monograph is often referred to as a Domperidon Certificate of Suitability (COS). The purpose of a Domperidon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Domperidon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Domperidon to their clients by showing that a Domperidon CEP has been issued for it. The manufacturer submits a Domperidon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Domperidon CEP holder for the record. Additionally, the data presented in the Domperidon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Domperidon DMF.
A Domperidon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Domperidon 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 Domperidon suppliers with CEP (COS) on PharmaCompass.
A Domperidon written confirmation (Domperidon WC) is an official document issued by a regulatory agency to a Domperidon manufacturer, verifying that the manufacturing facility of a Domperidon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Domperidon APIs or Domperidon finished pharmaceutical products to another nation, regulatory agencies frequently require a Domperidon WC (written confirmation) as part of the regulatory process.
click here to find a list of Domperidon 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 Domperidon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Domperidon 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 Domperidon 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 Domperidon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Domperidon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Domperidon suppliers with NDC on PharmaCompass.
Domperidon 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 Domperidon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Domperidon GMP manufacturer or Domperidon GMP API supplier for your needs.
A Domperidon CoA (Certificate of Analysis) is a formal document that attests to Domperidon's compliance with Domperidon specifications and serves as a tool for batch-level quality control.
Domperidon CoA mostly includes findings from lab analyses of a specific batch. For each Domperidon 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.
Domperidon may be tested according to a variety of international standards, such as European Pharmacopoeia (Domperidon EP), Domperidon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Domperidon USP).
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