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PharmaCompass offers a list of Ceftizoxime 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 Ceftizoxime Sodium manufacturer or Ceftizoxime Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ceftizoxime Sodium manufacturer or Ceftizoxime Sodium supplier.
PharmaCompass also assists you with knowing the Ceftizoxime Sodium API Price utilized in the formulation of products. Ceftizoxime Sodium API Price is not always fixed or binding as the Ceftizoxime Sodium Price is obtained through a variety of data sources. The Ceftizoxime Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ceftizoxime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ceftizoxime, including repackagers and relabelers. The FDA regulates Ceftizoxime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ceftizoxime 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 Ceftizoxime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ceftizoxime supplier is an individual or a company that provides Ceftizoxime active pharmaceutical ingredient (API) or Ceftizoxime finished formulations upon request. The Ceftizoxime suppliers may include Ceftizoxime API manufacturers, exporters, distributors and traders.
click here to find a list of Ceftizoxime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ceftizoxime DMF (Drug Master File) is a document detailing the whole manufacturing process of Ceftizoxime active pharmaceutical ingredient (API) in detail. Different forms of Ceftizoxime DMFs exist exist since differing nations have different regulations, such as Ceftizoxime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ceftizoxime DMF submitted to regulatory agencies in the US is known as a USDMF. Ceftizoxime USDMF includes data on Ceftizoxime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ceftizoxime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ceftizoxime suppliers with USDMF on PharmaCompass.
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 Ceftizoxime Drug Master File in Japan (Ceftizoxime JDMF) empowers Ceftizoxime 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 Ceftizoxime JDMF during the approval evaluation for pharmaceutical products. At the time of Ceftizoxime JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Ceftizoxime suppliers with JDMF 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 Ceftizoxime Drug Master File in Korea (Ceftizoxime KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ceftizoxime. The MFDS reviews the Ceftizoxime KDMF as part of the drug registration process and uses the information provided in the Ceftizoxime KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ceftizoxime 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 Ceftizoxime API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ceftizoxime suppliers with KDMF on PharmaCompass.
A Ceftizoxime CEP of the European Pharmacopoeia monograph is often referred to as a Ceftizoxime Certificate of Suitability (COS). The purpose of a Ceftizoxime CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ceftizoxime EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ceftizoxime to their clients by showing that a Ceftizoxime CEP has been issued for it. The manufacturer submits a Ceftizoxime CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ceftizoxime CEP holder for the record. Additionally, the data presented in the Ceftizoxime CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ceftizoxime DMF.
A Ceftizoxime CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ceftizoxime 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 Ceftizoxime suppliers with CEP (COS) on PharmaCompass.
Ceftizoxime 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 Ceftizoxime 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 Ceftizoxime GMP manufacturer or Ceftizoxime GMP API supplier for your needs.
A Ceftizoxime CoA (Certificate of Analysis) is a formal document that attests to Ceftizoxime's compliance with Ceftizoxime specifications and serves as a tool for batch-level quality control.
Ceftizoxime CoA mostly includes findings from lab analyses of a specific batch. For each Ceftizoxime 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.
Ceftizoxime may be tested according to a variety of international standards, such as European Pharmacopoeia (Ceftizoxime EP), Ceftizoxime JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ceftizoxime USP).
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