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