Synopsis
0
CEP/COS
0
VMF
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
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]JDMF
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]KDMF
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 
INTERMEDIATES 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]Listed Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
10 Dec 2015
// PHARMABIZ
Global Sales Information
Annual Reports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
APIs
Reply
30 Mar 2023
Reply
20 Jan 2023
Reply
04 Feb 2021
Reply
14 Oct 2020
Reply
31 Aug 2020
Reply
19 Mar 2020
Reply
13 Mar 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
FDF DOSSIERS
Reply
31 Oct 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
ABOUT THIS PAGE
A Rebamipide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rebamipide, including repackagers and relabelers. The FDA regulates Rebamipide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rebamipide 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 Rebamipide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rebamipide supplier is an individual or a company that provides Rebamipide active pharmaceutical ingredient (API) or Rebamipide finished formulations upon request. The Rebamipide suppliers may include Rebamipide API manufacturers, exporters, distributors and traders.
click here to find a list of Rebamipide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rebamipide DMF (Drug Master File) is a document detailing the whole manufacturing process of Rebamipide active pharmaceutical ingredient (API) in detail. Different forms of Rebamipide DMFs exist exist since differing nations have different regulations, such as Rebamipide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rebamipide DMF submitted to regulatory agencies in the US is known as a USDMF. Rebamipide USDMF includes data on Rebamipide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rebamipide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rebamipide 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 Rebamipide Drug Master File in Japan (Rebamipide JDMF) empowers Rebamipide 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 Rebamipide JDMF during the approval evaluation for pharmaceutical products. At the time of Rebamipide 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 Rebamipide 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 Rebamipide Drug Master File in Korea (Rebamipide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rebamipide. The MFDS reviews the Rebamipide KDMF as part of the drug registration process and uses the information provided in the Rebamipide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rebamipide 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 Rebamipide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rebamipide suppliers with KDMF on PharmaCompass.
A Rebamipide written confirmation (Rebamipide WC) is an official document issued by a regulatory agency to a Rebamipide manufacturer, verifying that the manufacturing facility of a Rebamipide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rebamipide APIs or Rebamipide finished pharmaceutical products to another nation, regulatory agencies frequently require a Rebamipide WC (written confirmation) as part of the regulatory process.
click here to find a list of Rebamipide 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 Rebamipide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rebamipide 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 Rebamipide 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 Rebamipide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rebamipide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rebamipide suppliers with NDC on PharmaCompass.
Rebamipide 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 Rebamipide 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 Rebamipide GMP manufacturer or Rebamipide GMP API supplier for your needs.
A Rebamipide CoA (Certificate of Analysis) is a formal document that attests to Rebamipide's compliance with Rebamipide specifications and serves as a tool for batch-level quality control.
Rebamipide CoA mostly includes findings from lab analyses of a specific batch. For each Rebamipide 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.
Rebamipide may be tested according to a variety of international standards, such as European Pharmacopoeia (Rebamipide EP), Rebamipide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rebamipide USP).
LOOKING FOR A SUPPLIER?
Share
Comment (2)
