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