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