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