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