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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 Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ceftizoxime Sodium, including repackagers and relabelers. The FDA regulates Ceftizoxime Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ceftizoxime 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 Ceftizoxime Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ceftizoxime Sodium supplier is an individual or a company that provides Ceftizoxime Sodium active pharmaceutical ingredient (API) or Ceftizoxime Sodium finished formulations upon request. The Ceftizoxime Sodium suppliers may include Ceftizoxime Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Ceftizoxime Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ceftizoxime Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Ceftizoxime Sodium active pharmaceutical ingredient (API) in detail. Different forms of Ceftizoxime Sodium DMFs exist exist since differing nations have different regulations, such as Ceftizoxime Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ceftizoxime Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Ceftizoxime Sodium USDMF includes data on Ceftizoxime Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ceftizoxime Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ceftizoxime Sodium 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 Sodium Drug Master File in Japan (Ceftizoxime Sodium JDMF) empowers Ceftizoxime Sodium 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 Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Ceftizoxime Sodium 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 Sodium 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 Sodium Drug Master File in Korea (Ceftizoxime Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ceftizoxime Sodium. The MFDS reviews the Ceftizoxime Sodium KDMF as part of the drug registration process and uses the information provided in the Ceftizoxime Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ceftizoxime 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 Ceftizoxime Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ceftizoxime Sodium suppliers with KDMF on PharmaCompass.
A Ceftizoxime Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Ceftizoxime Sodium Certificate of Suitability (COS). The purpose of a Ceftizoxime Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ceftizoxime Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ceftizoxime Sodium to their clients by showing that a Ceftizoxime Sodium CEP has been issued for it. The manufacturer submits a Ceftizoxime Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ceftizoxime Sodium CEP holder for the record. Additionally, the data presented in the Ceftizoxime Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ceftizoxime Sodium DMF.
A Ceftizoxime Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ceftizoxime 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 Ceftizoxime Sodium suppliers with CEP (COS) on PharmaCompass.
Ceftizoxime 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 Ceftizoxime 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 Ceftizoxime Sodium GMP manufacturer or Ceftizoxime Sodium GMP API supplier for your needs.
A Ceftizoxime Sodium CoA (Certificate of Analysis) is a formal document that attests to Ceftizoxime Sodium's compliance with Ceftizoxime Sodium specifications and serves as a tool for batch-level quality control.
Ceftizoxime Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Ceftizoxime 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.
Ceftizoxime Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Ceftizoxime Sodium EP), Ceftizoxime Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ceftizoxime Sodium USP).
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