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JDMF
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Australia
DRUG PRODUCT COMPOSITIONS
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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]Related Excipient Companies
Evonik
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
21
PharmaCompass offers a list of Cefprozil 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 Cefprozil manufacturer or Cefprozil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefprozil manufacturer or Cefprozil supplier.
PharmaCompass also assists you with knowing the Cefprozil API Price utilized in the formulation of products. Cefprozil API Price is not always fixed or binding as the Cefprozil Price is obtained through a variety of data sources. The Cefprozil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cefzil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefzil, including repackagers and relabelers. The FDA regulates Cefzil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefzil 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 Cefzil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefzil supplier is an individual or a company that provides Cefzil active pharmaceutical ingredient (API) or Cefzil finished formulations upon request. The Cefzil suppliers may include Cefzil API manufacturers, exporters, distributors and traders.
click here to find a list of Cefzil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefzil DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefzil active pharmaceutical ingredient (API) in detail. Different forms of Cefzil DMFs exist exist since differing nations have different regulations, such as Cefzil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefzil DMF submitted to regulatory agencies in the US is known as a USDMF. Cefzil USDMF includes data on Cefzil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefzil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefzil 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 Cefzil Drug Master File in Korea (Cefzil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefzil. The MFDS reviews the Cefzil KDMF as part of the drug registration process and uses the information provided in the Cefzil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefzil 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 Cefzil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefzil suppliers with KDMF on PharmaCompass.
A Cefzil CEP of the European Pharmacopoeia monograph is often referred to as a Cefzil Certificate of Suitability (COS). The purpose of a Cefzil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefzil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefzil to their clients by showing that a Cefzil CEP has been issued for it. The manufacturer submits a Cefzil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefzil CEP holder for the record. Additionally, the data presented in the Cefzil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefzil DMF.
A Cefzil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefzil 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 Cefzil suppliers with CEP (COS) on PharmaCompass.
A Cefzil written confirmation (Cefzil WC) is an official document issued by a regulatory agency to a Cefzil manufacturer, verifying that the manufacturing facility of a Cefzil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefzil APIs or Cefzil finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefzil WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefzil 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 Cefzil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefzil 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 Cefzil 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 Cefzil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefzil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefzil suppliers with NDC on PharmaCompass.
Cefzil 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 Cefzil 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 Cefzil GMP manufacturer or Cefzil GMP API supplier for your needs.
A Cefzil CoA (Certificate of Analysis) is a formal document that attests to Cefzil's compliance with Cefzil specifications and serves as a tool for batch-level quality control.
Cefzil CoA mostly includes findings from lab analyses of a specific batch. For each Cefzil 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.
Cefzil may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefzil EP), Cefzil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefzil USP).
