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