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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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 - POWDER;INTRAVENOUS - EQ 0.5GM BASE;2...DOSAGE - POWDER;INTRAVENOUS - EQ 0.5GM BASE;2GM/VIAL
USFDA APPLICATION NUMBER - 206494
DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50578
DOSAGE - INJECTABLE;INJECTION - 2GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50578
DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL **...DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50578
DOSAGE - INJECTABLE;INJECTION - 6GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50578
DOSAGE - INJECTABLE;INJECTION - EQ 20MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 20MG BASE/ML
USFDA APPLICATION NUMBER - 50634
DOSAGE - INJECTABLE;INJECTION - EQ 40MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 40MG BASE/ML
USFDA APPLICATION NUMBER - 50634
DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE
USFDA APPLICATION NUMBER - 50823
DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE
USFDA APPLICATION NUMBER - 50823
Related Excipient Companies
Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
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Fillers, Diluents & Binders
Taste Masking
Co-Processed Excipients
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
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ABOUT THIS PAGE
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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 AVYCAZ manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AVYCAZ, including repackagers and relabelers. The FDA regulates AVYCAZ manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AVYCAZ 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 AVYCAZ manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AVYCAZ supplier is an individual or a company that provides AVYCAZ active pharmaceutical ingredient (API) or AVYCAZ finished formulations upon request. The AVYCAZ suppliers may include AVYCAZ API manufacturers, exporters, distributors and traders.
click here to find a list of AVYCAZ suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AVYCAZ DMF (Drug Master File) is a document detailing the whole manufacturing process of AVYCAZ active pharmaceutical ingredient (API) in detail. Different forms of AVYCAZ DMFs exist exist since differing nations have different regulations, such as AVYCAZ USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AVYCAZ DMF submitted to regulatory agencies in the US is known as a USDMF. AVYCAZ USDMF includes data on AVYCAZ's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AVYCAZ USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AVYCAZ 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 AVYCAZ Drug Master File in Japan (AVYCAZ JDMF) empowers AVYCAZ 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 AVYCAZ JDMF during the approval evaluation for pharmaceutical products. At the time of AVYCAZ 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 AVYCAZ 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 AVYCAZ Drug Master File in Korea (AVYCAZ KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AVYCAZ. The MFDS reviews the AVYCAZ KDMF as part of the drug registration process and uses the information provided in the AVYCAZ KDMF to evaluate the safety and efficacy of the drug.
After submitting a AVYCAZ 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 AVYCAZ API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AVYCAZ suppliers with KDMF on PharmaCompass.
A AVYCAZ CEP of the European Pharmacopoeia monograph is often referred to as a AVYCAZ Certificate of Suitability (COS). The purpose of a AVYCAZ CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AVYCAZ EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AVYCAZ to their clients by showing that a AVYCAZ CEP has been issued for it. The manufacturer submits a AVYCAZ CEP (COS) as part of the market authorization procedure, and it takes on the role of a AVYCAZ CEP holder for the record. Additionally, the data presented in the AVYCAZ CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AVYCAZ DMF.
A AVYCAZ CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AVYCAZ 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 AVYCAZ suppliers with CEP (COS) on PharmaCompass.
A AVYCAZ written confirmation (AVYCAZ WC) is an official document issued by a regulatory agency to a AVYCAZ manufacturer, verifying that the manufacturing facility of a AVYCAZ active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AVYCAZ APIs or AVYCAZ finished pharmaceutical products to another nation, regulatory agencies frequently require a AVYCAZ WC (written confirmation) as part of the regulatory process.
click here to find a list of AVYCAZ 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 AVYCAZ as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AVYCAZ 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 AVYCAZ 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 AVYCAZ and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AVYCAZ NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of AVYCAZ suppliers with NDC on PharmaCompass.
AVYCAZ 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 AVYCAZ 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 AVYCAZ GMP manufacturer or AVYCAZ GMP API supplier for your needs.
A AVYCAZ CoA (Certificate of Analysis) is a formal document that attests to AVYCAZ's compliance with AVYCAZ specifications and serves as a tool for batch-level quality control.
AVYCAZ CoA mostly includes findings from lab analyses of a specific batch. For each AVYCAZ 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.
AVYCAZ may be tested according to a variety of international standards, such as European Pharmacopoeia (AVYCAZ EP), AVYCAZ JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AVYCAZ USP).
