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PharmaCompass offers a list of Rebamipide 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 Rebamipide manufacturer or Rebamipide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rebamipide manufacturer or Rebamipide supplier.
PharmaCompass also assists you with knowing the Rebamipide API Price utilized in the formulation of products. Rebamipide API Price is not always fixed or binding as the Rebamipide Price is obtained through a variety of data sources. The Rebamipide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid, including repackagers and relabelers. The FDA regulates (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid supplier is an individual or a company that provides (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid active pharmaceutical ingredient (API) or (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid finished formulations upon request. The (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid suppliers may include (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid API manufacturers, exporters, distributors and traders.
click here to find a list of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid active pharmaceutical ingredient (API) in detail. Different forms of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid DMFs exist exist since differing nations have different regulations, such as (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid DMF submitted to regulatory agencies in the US is known as a USDMF. (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid USDMF includes data on (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid Drug Master File in Japan ((+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid JDMF) empowers (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid JDMF during the approval evaluation for pharmaceutical products. At the time of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid Drug Master File in Korea ((+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid. The MFDS reviews the (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid KDMF as part of the drug registration process and uses the information provided in the (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid suppliers with KDMF on PharmaCompass.
A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid written confirmation ((+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid WC) is an official document issued by a regulatory agency to a (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid manufacturer, verifying that the manufacturing facility of a (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid APIs or (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid finished pharmaceutical products to another nation, regulatory agencies frequently require a (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid WC (written confirmation) as part of the regulatory process.
click here to find a list of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid suppliers with NDC on PharmaCompass.
(+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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 (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid GMP manufacturer or (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid GMP API supplier for your needs.
A (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid CoA (Certificate of Analysis) is a formal document that attests to (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid's compliance with (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid specifications and serves as a tool for batch-level quality control.
(+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid CoA mostly includes findings from lab analyses of a specific batch. For each (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid 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.
(+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid may be tested according to a variety of international standards, such as European Pharmacopoeia ((+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid EP), (+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((+-)-alpha-((4-Chlorobenzoyl)amino)-1,2-dihydro-2-oxo-4-quinolinepropanic acid USP).
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