Synopsis
0
JDMF
0
VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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- INJECTABLE;INJECTION - EQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INJECTION - EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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INTRAVENOUS - EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Related Excipient Companies
Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Fillers, Diluents & Binders
Co-Processed Excipients
Taste Masking
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
61
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 Furoxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Furoxil, including repackagers and relabelers. The FDA regulates Furoxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Furoxil 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 Furoxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Furoxil supplier is an individual or a company that provides Furoxil active pharmaceutical ingredient (API) or Furoxil finished formulations upon request. The Furoxil suppliers may include Furoxil API manufacturers, exporters, distributors and traders.
click here to find a list of Furoxil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Furoxil DMF (Drug Master File) is a document detailing the whole manufacturing process of Furoxil active pharmaceutical ingredient (API) in detail. Different forms of Furoxil DMFs exist exist since differing nations have different regulations, such as Furoxil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Furoxil DMF submitted to regulatory agencies in the US is known as a USDMF. Furoxil USDMF includes data on Furoxil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Furoxil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Furoxil 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 Furoxil Drug Master File in Korea (Furoxil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Furoxil. The MFDS reviews the Furoxil KDMF as part of the drug registration process and uses the information provided in the Furoxil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Furoxil 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 Furoxil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Furoxil suppliers with KDMF on PharmaCompass.
A Furoxil CEP of the European Pharmacopoeia monograph is often referred to as a Furoxil Certificate of Suitability (COS). The purpose of a Furoxil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Furoxil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Furoxil to their clients by showing that a Furoxil CEP has been issued for it. The manufacturer submits a Furoxil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Furoxil CEP holder for the record. Additionally, the data presented in the Furoxil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Furoxil DMF.
A Furoxil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Furoxil 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 Furoxil suppliers with CEP (COS) on PharmaCompass.
A Furoxil written confirmation (Furoxil WC) is an official document issued by a regulatory agency to a Furoxil manufacturer, verifying that the manufacturing facility of a Furoxil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Furoxil APIs or Furoxil finished pharmaceutical products to another nation, regulatory agencies frequently require a Furoxil WC (written confirmation) as part of the regulatory process.
click here to find a list of Furoxil 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 Furoxil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Furoxil 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 Furoxil 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 Furoxil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Furoxil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Furoxil suppliers with NDC on PharmaCompass.
Furoxil 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 Furoxil 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 Furoxil GMP manufacturer or Furoxil GMP API supplier for your needs.
A Furoxil CoA (Certificate of Analysis) is a formal document that attests to Furoxil's compliance with Furoxil specifications and serves as a tool for batch-level quality control.
Furoxil CoA mostly includes findings from lab analyses of a specific batch. For each Furoxil 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.
Furoxil may be tested according to a variety of international standards, such as European Pharmacopoeia (Furoxil EP), Furoxil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Furoxil USP).
