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