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