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USDMF
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DOSAGE - INJECTABLE;INJECTION - EQ 1.5GM BASE...DOSAGE - INJECTABLE;INJECTION - EQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50558
DOSAGE - INJECTABLE;INJECTION - EQ 7.5GM BASE...DOSAGE - INJECTABLE;INJECTION - EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50558
DOSAGE - INJECTABLE;INTRAMUSCULAR, INTRAVENOU...DOSAGE - INJECTABLE;INTRAMUSCULAR, INTRAVENOUS - EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50558
DOSAGE - INJECTABLE;INJECTION - EQ 30MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 30MG BASE/ML
USFDA APPLICATION NUMBER - 50643
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Actylis
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ABOUT THIS PAGE
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PharmaCompass offers a list of Cefuroxime Sodium 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 Sodium manufacturer or Cefuroxime Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefuroxime Sodium manufacturer or Cefuroxime Sodium supplier.
PharmaCompass also assists you with knowing the Cefuroxime Sodium API Price utilized in the formulation of products. Cefuroxime Sodium API Price is not always fixed or binding as the Cefuroxime Sodium Price is obtained through a variety of data sources. The Cefuroxime Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sodium cefuroxime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium cefuroxime, including repackagers and relabelers. The FDA regulates Sodium cefuroxime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium 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 Sodium cefuroxime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium cefuroxime supplier is an individual or a company that provides Sodium cefuroxime active pharmaceutical ingredient (API) or Sodium cefuroxime finished formulations upon request. The Sodium cefuroxime suppliers may include Sodium cefuroxime API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium cefuroxime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium cefuroxime DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium cefuroxime active pharmaceutical ingredient (API) in detail. Different forms of Sodium cefuroxime DMFs exist exist since differing nations have different regulations, such as Sodium cefuroxime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium cefuroxime DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium cefuroxime USDMF includes data on Sodium cefuroxime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium cefuroxime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium 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 Sodium cefuroxime Drug Master File in Korea (Sodium cefuroxime KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sodium cefuroxime. The MFDS reviews the Sodium cefuroxime KDMF as part of the drug registration process and uses the information provided in the Sodium cefuroxime KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sodium 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 Sodium cefuroxime API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sodium cefuroxime suppliers with KDMF on PharmaCompass.
A Sodium cefuroxime CEP of the European Pharmacopoeia monograph is often referred to as a Sodium cefuroxime Certificate of Suitability (COS). The purpose of a Sodium cefuroxime CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium cefuroxime EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium cefuroxime to their clients by showing that a Sodium cefuroxime CEP has been issued for it. The manufacturer submits a Sodium cefuroxime CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium cefuroxime CEP holder for the record. Additionally, the data presented in the Sodium cefuroxime CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium cefuroxime DMF.
A Sodium cefuroxime CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium 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 Sodium cefuroxime suppliers with CEP (COS) on PharmaCompass.
A Sodium cefuroxime written confirmation (Sodium cefuroxime WC) is an official document issued by a regulatory agency to a Sodium cefuroxime manufacturer, verifying that the manufacturing facility of a Sodium cefuroxime active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium cefuroxime APIs or Sodium cefuroxime finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium cefuroxime WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium 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 Sodium cefuroxime as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium 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 Sodium 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 Sodium cefuroxime and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium cefuroxime NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium cefuroxime suppliers with NDC on PharmaCompass.
Sodium 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 Sodium 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 Sodium cefuroxime GMP manufacturer or Sodium cefuroxime GMP API supplier for your needs.
A Sodium cefuroxime CoA (Certificate of Analysis) is a formal document that attests to Sodium cefuroxime's compliance with Sodium cefuroxime specifications and serves as a tool for batch-level quality control.
Sodium cefuroxime CoA mostly includes findings from lab analyses of a specific batch. For each Sodium 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.
Sodium cefuroxime may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium cefuroxime EP), Sodium cefuroxime JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium cefuroxime USP).
