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USDMF
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DOSAGE - SOLUTION;INTRAVENOUS - EQ 1GM BASE/5...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
USFDA APPLICATION NUMBER - 207131
DOSAGE - SOLUTION;INTRAVENOUS - EQ 2GM BASE/1...DOSAGE - SOLUTION;INTRAVENOUS - EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
USFDA APPLICATION NUMBER - 207131
DOSAGE - SOLUTION;INTRAVENOUS - EQ 3GM BASE/1...DOSAGE - SOLUTION;INTRAVENOUS - EQ 3GM BASE/150ML (EQ 20MG BASE/ML)
USFDA APPLICATION NUMBER - 207131
DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL
USFDA APPLICATION NUMBER - 50779
DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/VIAL
USFDA APPLICATION NUMBER - 50779
DOSAGE - INJECTABLE;INJECTION - EQ 3GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 3GM BASE/VIAL
USFDA APPLICATION NUMBER - 50779
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SPI Pharma
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ABOUT THIS PAGE
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PharmaCompass offers a list of Cefazolin 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 Cefazolin Sodium manufacturer or Cefazolin Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefazolin Sodium manufacturer or Cefazolin Sodium supplier.
PharmaCompass also assists you with knowing the Cefazolin Sodium API Price utilized in the formulation of products. Cefazolin Sodium API Price is not always fixed or binding as the Cefazolin Sodium Price is obtained through a variety of data sources. The Cefazolin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER, including repackagers and relabelers. The FDA regulates ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER supplier is an individual or a company that provides ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER active pharmaceutical ingredient (API) or ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER finished formulations upon request. The ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER suppliers may include ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER API manufacturers, exporters, distributors and traders.
click here to find a list of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER DMF (Drug Master File) is a document detailing the whole manufacturing process of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER active pharmaceutical ingredient (API) in detail. Different forms of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER DMFs exist exist since differing nations have different regulations, such as ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER DMF submitted to regulatory agencies in the US is known as a USDMF. ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER USDMF includes data on ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Master File in Japan (ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER JDMF) empowers ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER JDMF during the approval evaluation for pharmaceutical products. At the time of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Master File in Korea (ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER. The MFDS reviews the ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER KDMF as part of the drug registration process and uses the information provided in the ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER KDMF to evaluate the safety and efficacy of the drug.
After submitting a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER suppliers with KDMF on PharmaCompass.
A ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER CEP of the European Pharmacopoeia monograph is often referred to as a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER Certificate of Suitability (COS). The purpose of a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER to their clients by showing that a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER CEP has been issued for it. The manufacturer submits a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER CEP (COS) as part of the market authorization procedure, and it takes on the role of a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER CEP holder for the record. Additionally, the data presented in the ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER DMF.
A ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER suppliers with CEP (COS) on PharmaCompass.
A ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER written confirmation (ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER WC) is an official document issued by a regulatory agency to a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER manufacturer, verifying that the manufacturing facility of a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER APIs or ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER finished pharmaceutical products to another nation, regulatory agencies frequently require a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER WC (written confirmation) as part of the regulatory process.
click here to find a list of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER suppliers with NDC on PharmaCompass.
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER GMP manufacturer or ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER GMP API supplier for your needs.
A ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER CoA (Certificate of Analysis) is a formal document that attests to ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER's compliance with ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER specifications and serves as a tool for batch-level quality control.
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER CoA mostly includes findings from lab analyses of a specific batch. For each ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER 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.
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER may be tested according to a variety of international standards, such as European Pharmacopoeia (ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER EP), ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER USP).
