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- INJECTABLE;INJECTION - EQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INJECTION - EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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INTRAVENOUS - EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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