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